Q&As

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REACH

Ambito di applicazione del regolamento REACH

Does REACH apply to substances (either on their own, in mixtures or in articles) manufactured or imported in volumes below 1 tonne per year?

Yes, because besides registration there are several obligations under REACH that apply irrespective of tonnage. These include restrictions, authorisation and communication in the supply chain (such as the provision of safety data sheets). The one tonne per year threshold applies to registration only.

To identify your obligations, we recommend you to use the Navigator tool: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations

Do substances used in biocides and plant protection products (PPP) have to be registered under REACH?

Active substances for use in biocidal products are regarded as already registered, as biocidal products and their active ingredients are covered by Regulation (EU) 528/2012 (Biocidal Products Regulation). However, several conditions have to be fulfilled to benefit from the exemption. These conditions are laid down in Article 15(2) of the REACH Regulation and explained in section 2.2.4.1- 'Substance for use in biocidal products' of the Guidance on registration http://echa.europa.eu/guidance-documents/guidance-on-reach.

Active substances for use in plant protection products (PPPs) are regarded as registered as the plant protection products and their active ingredients are covered by Regulation (EC) 1107/2009. Please note that even though co-formulants are mentioned in Article 15(1) of the REACH Regulation, currently they do not meet the conditions laid down in this Article. Therefore co-formulants used in plant protection products do not qualify for the exemption and are not regarded as registered. This is further explained in section 2.2.4.2- 'Substance for use in plant protection products' of the Guidance on registration http://echa.europa.eu/guidance-documents/guidance-on-reach.

It is important to note, that only the quantities of the active substance for use in biocidal products and for use in PPPs are considered registered under REACH. Thus, if the substance is not used as an active ingredient in a biocidal product or a PPP, then the exemption would not apply to this other use and the quantity of the substance for the non-biocidal or non-PPP use would have to be registered.

 

Does REACH apply to substances occurring in nature or to their synthetic analogues?

REACH applies both to substances occurring in nature, as defined by Article 3(39) of REACH, and to their synthetic analogues.

However, Annex V to REACH states that the following substances occurring in nature are exempted from registration if they are not chemically modified: minerals, ores, ore concentrates, raw and processed natural gas, crude oil and coal. These substances can only be processed by certain means (e.g. dissolution in water, flotation), which are specified in Article 3(39) of REACH and do not include chemical modification (Article 3(40)).

Other substances occurring in nature are also exempted from registration if they are not chemically modified, unless:

  • they meet the criteria for classification as dangerous according to the CLP Regulation (Regulation 1272/2008), or
  • they are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII, or
  • they were identified in accordance with Article 59(1) at least two years previously as substances giving rise to an equivalent level of concern as set out in Article 57(f).

Further explanations and background information on the different exemptions in Annex V are included in section 2.2.3.4 - 'Substances covered by Annex V of the REACH Regulation' of the Guidance on registration: http://www.echa.europa.eu/guidance-documents/guidance-on-reach

The REACH Registration Q&As provide guidance on substances occurring in nature that are obtained by extraction processes.

For particular guidance on polymer substances occurring in nature, see section 3.2.1.3 - 'Case of a natural polymer or a chemically modified natural polymer' of the Guidance for monomers and polymers: http://www.echa.europa.eu/guidance-documents/guidance-on-reach

Since the synthetic analogues of naturally occurring substances do not meet the criteria for substances occurring in nature as defined in Article 3(39) of REACH, any manufacturer or importer of these substances in quantities of one tonne or more per year is required to register them.

 

 

Are modified substances derived from substances listed in Annex IV also exempt from registration?

Substances listed in Annex IV to REACH are exempt from registration. Modified substances derived from these substances are also exempt if the modified substance is still covered by the same EINECS entry; whether the same EINECS entry applies is a case-by-case decision. For example, for plant oils such as soybean oil (EINECS no 232-274-4; CAS no 8001-22-7) the physically modified derivatives are explicitly covered in the EINECS entry. Whereas chemical modification (e.g. hydrogenation) is not mentioned and hence considered not to be covered. For further information, see Article 3(40) of REACH and Section 2.2.3.3- 'Substances included in Annex IV of the REACH Regulation' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach

Do substances at nano-scale fall under the scope of REACH?

Yes, they do and their health and environment properties must be assessed in accordance with the provisions of the REACH Regulation. Potential registrants should first consider whether they have obligations under REACH, irrespective of the particle size of the substances. Once it is established that the substance falls within the scope of REACH, further investigation of the detailed provisions of REACH may indicate that different provisions apply according to the hazard properties associated with the particle size of the substances. The evolving science of nanotechnology may necessitate further requirements in the future to reflect the particular properties of nanoparticles.

 

Is biomethane obtained by the purification of biogas exempted from registration under REACH?

Yes, biomethane obtained by the purification of biogas is considered to be covered by the exemption from registration according to Annex V entry 12 to REACH. This exemption does not refer to biomethane as such, but to biogas (consisting mainly of methane) produced by the biological breakdown of organic matter (e.g. agricultural waste, municipal waste, sewage) in the absence of oxygen. Nevertheless, biomethane obtained by the purification of biogas to remove undesirable components is still considered as biogas and is, therefore, exempted from registration according to Annex V entry 12 to REACH.

For methane processed from raw natural gas, the exemption in Annex V entry 7 to REACH applies. Methane obtained from other sources than fossils is not regarded as natural gas and is, therefore, not covered by this entry. 

Autorizzazione

a) General / Procedure

Are any substances already subject to authorisation?

Yes. The List of Substances Subject to Authorisation (Annex XIV of the REACH Regulation) includes several substances.

Substances are regularly added to Annex XIV by the European Commission, on the basis of recommendations issued by ECHA. The link to the updated Annex XIV can be found on ECHA's website at: http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list/authorisation-list.

Further details on the procedure for the inclusion of substances to Annex XIV of the REACH Regulation are available in FAQ ID=127, as well as on ECHA's website at: http://echa.europa.eu/regulations/reach/authorisation.

Where do I find the candidate list?

The Candidate List of Substances of Very High Concern (SVHC) for authorisation (Candidate List) is available on ECHA's website at: http://echa.europa.eu/candidate-list-table.

Additional substances are regularly included in the Candidate List, once these have been identified as SVHC.

How is a substance included in the Candidate List?
When the European Commission or a Member State considers that a substance may meet the criteria for identification as SVHC pursuant to Article 57 of REACH, ECHA (on request of the European Commission) or the Member State prepares an Annex XV SVHC dossier. With this Annex XV dossier ECHA or the Member State proposes the inclusion of the substance in the Candidate List by outlining the scientific evidence for identifying the substance as a SVHC.
 
ECHA's website includes a public registry of intentions in order to allow interested parties to be aware of the substances for which the authorities intend to submit Annex XV dossiers and thus facilitates timely preparation of the interested parties for commenting later in the process.
 
Once an Annex XV SVHC dossier has been prepared, a consultation of the Member States and interested parties is required, as specified in Article 59 of REACH. Further details on this consultation process are available on the ECHA website at http://echa.europa.eu/proposals-to-identify-substances-of-very-high-concern.
 
Following this consultation, the substance may be included in the Candidate List. The Candidate List is made available on ECHA's website in its last updated version at http://echa.europa.eu/candidate-list-table.
How is a substance from the Candidate List included in the "Authorisation List"?

Substances included in the Candidate List may be prioritised for inclusion in Annex XIV of the REACH Regulation (the so called "Authorisation List"). The Authorisation List contains all substances which, after a certain deadline, may only be used and/or placed on the market after a specific authorisation has been granted.

ECHA has to make at least every second year a recommendation of priority substances for inclusion in Annex XIV to the European Commission. Interested parties are invited to submit comments during this process. In addition, the Member State Committee issues an opinion on the recommendation before it is submitted to the European Commission. The European Commission then decides using the comitology procedure which of the recommended substances are to be included in Annex XIV and specifies, based on ECHA's recommendation, the transitional arrangements and, where relevant, exemptions and review periods. Further details on the procedure for inclusion of substances in Annex XIV of the REACH Regulation are available on ECHA's website at http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/recommendation-for-inclusion-in-the-authorisation-list .

How are authorisations granted for substances on the "Authorisation List"?

Applications for authorisation need to be made within the deadline (the so called "latest application date") that is specified in the "Authorisation List" for the corresponding substance if the applicant wishes to use the substance without interruption after the sunset date. Authorisation applications need to be submitted to ECHA. Third parties can provide information on alternative substances and technologies during public consultations on the uses that authorisation has been applied for. These are made available on ECHA's web-site. The ECHA Committees for Risk Assessment (RAC) and Socioeconomic Analysis (SEAC) give draft opinions on the application. Applicants will have the opportunity to comment on these draft opinions. RAC and SEAC will adopt final opinions and ECHA sends them to the European Commission. The European Commission decides, using the comitology procedure, whether an authorisation is granted or refused. ECHA will establish a publicly available database that will contain summaries of the Commission decisions. Further details on the application for authorisation procedure are available on ECHA's website under the following links:http://echa.europa.eu/regulations/reach/authorisation http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation

In which language do Applications for authorisation have to be submitted to ECHA?

Applications for authorisation may be submitted in any one of the official EU languages selected by the applicant. This means that the whole application, including the attachments and the Chemical Safety Report, must be submitted in the same language. This is a legal requirement based on Article 104(1) of REACH and Article 2 of Regulation No 1 of 15 April 1958.

Who can apply for an authorisation?

Only manufacturers, importers or downstream users of an Annex XIV substance as well as duly mandated Only Representatives can apply for an authorisation and be holders of a granted authorisation.

Can an Only Representative apply for an authorisation?

Yes. A duly mandated Only Representative ("OR") of a non-EU manufacturer can apply for an authorisation regardless of whether the OR assisted the non-EU entity with the registration of the Annex XIV substance to date. Once the OR has been appointed, it will have to comply with all other applicable obligations under REACH on behalf of the non-EU manufacturer who has appointed them. In cases where a non-EU manufacturer has not yet been appointed an OR, for example due to no obligation to register a substance, an OR may nevertheless be appointed. The OR will then represent the non-EU manufacturer with regard to all applicable REACH obligations.

Will only the person who submitted the authorisation application to ECHA benefit from the granted authorisation?

The holder of an authorisation is the person who submitted the authorisation application to ECHA. However, a downstream user may continue his use of an Annex XIV substance provided that this use is in accordance with the conditions of an authorisation granted to an actor up his supply chain for that use. Moreover, a manufacturer, importer or downstream user can continue placing an Annex XIV substance on the market for a use for which his immediate downstream user was granted an authorisation.

See supply chain coverage diagram

Who will decide on the granting and conditions of an authorisation?

The European Commission is responsible for taking decisions on Applications for authorisations. ECHA's Committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) will adopt opinions on the application for authorisation which will be taken into account by the Commission in its final decision.

Will my application be processed if I submit it outside the submission windows?

Yes. Be aware, however, that ECHA recommends applicants to submit their applications within submission windows that are published on its website. This concept ensures a batch wise process and a good synchronisation with the operational schedule of RAC and SEAC committees.

Why should I submit the application before the Latest Application Date?

You should apply before the Latest Application Date to be sure that you will be able to continue to use the substance while your application is being treated by ECHA and the Commission. In other words, you should apply early to take advantage of the transitional arrangements and continue your use after the sunset date even if no decision has been taken by the Commission.

The date of submission of the application will be considered as the date on which your application has been received for the purpose of benefitting from the transitional arrangements described in Article 58(1)(c)(ii), provided that you pass the business rules checks. This date is relevant if you intend to take advantage of these transitional arrangements and continue your use after the sunset date if no decision has been taken by the Commission. The following two situations may occur:

1. You have submitted your application early enough and it passes business rules checks before the latest application date: in this case you will benefit from the transitional arrangements described in Article 58(1)(c)(ii) provided that you pay your invoice in due time.

2. You have submitted your application just before the latest application date but it passes the business rules after the latest application date: in this case you can benefit from the transitional arrangements described in Article 58(1)(c)(ii) provided that you pay your invoice in due time. If your application does not pass the business rules checks you will have to resubmit your application. If you resubmit your application after the latest application date you will not be able to benefit from the transitional arrangements.

Therefore ECHA recommends that you submit your application during the submission window three months earlier than the latest application date. If you choose to submit in the latest submission window, ECHA recommends that you do so at the very beginning of the window.

The date from which the 10 months' time limit for the Committees to prepare their draft opinions starts is the date on which ECHA has received the application fee.

Will my application be processed if I submit it after the Latest Application Date?

Yes, the application will still be accepted for processing and evaluated by RAC and SEAC. However, the transitional arrangements under Article 58 (1)(c)(ii) of the REACH Regulation will not apply. These transitional arrangements would allow the applicant to use the substance even after the Sunset Date if no decision has been taken by the Commission.

Are end points related to the intrinsic properties of Annex XIV more critical than other end points?

If the substance has a threshold you need to demonstrate that the risks associated for the hazard endpoint mentioned in Annex XIV are adequately controlled. If the substance does not have a threshold, you need to demonstrate minimisation of emissions and exposure as far as possible. The Chemical Safety Report (CSR) should therefore focus on the Annex XIV endpoint but information on other endpoints might be necessary for comparing the risks with the alternatives. The alternatives should result in reduced overall risks to human health and the environment. Therefore, it is important not only to consider the risks arising from the Annex XIV endpoint but also on all other possible risks from the Annex XIV substance and the alternatives.

Can the decision taken by the Commission be different for the several uses included in my application?

A decision on authorising a use can be different from one use to another. Thus, if certain uses are authorised and others are not, then the non-authorised uses are no longer permitted.

How RAC and SEAC work together? Can they disagree with each other?

The primary objective of RAC and SEAC is to provide consistent opinions of high scientific quality to support the desicion making of the European Commission. The remits of both Committees are clear and cooperation between them is ensured by agreed procedures.
See also: http://echa.europa.eu/documents/10162/13555/common_approach_rac_seac_en.pdf

Can a distributor be considered as the immediate Downstream User (DU) in the context of article 56(1) (e) and apply for an authorisation?

No. A distributor who only stores the Annex XIV substance before placing it on the market cannot be considered as Downstream Users in the context of Article 56(1)(e) (see Article 3(14) of the REACH Regulation). However, actors can no longer be considered as distributors if they use the substances themselves (e.g. repackaging). Then they are considered as downstream users and, as such, shall apply for authorisation (and may cover uses of their downstream users), unless already covered by an authorisation.

Distributors (i.e. entities who only store the substance) are "transparent" in the supply chain if they do not "use" the substance. Therefore an application granted to a downstream user should be understood as covering the manufacturer/importer of that substance and all the distributors in between. However, this only applies in cases where there are no actors using the substance (e.g. formulators, repackaging companies, etc.) between the downstream user applicant and the manufacturer/importer. Also, distributors have to communicate the relevant information (e.g. safety data sheets, authorisation numbers) to their downstream users.

Can a Downstream User apply for uses upstream in the supply chain?

No. A downstream user (Company B) holding an authorisation for his use(s) (for instance, an end-use) can be supplied by an actor (Company A) up his supply chain (for instance, a formulator) in accordance with Article 56(1)(e). However, the use of Company A (that is the formulation of the Annex XIV substance) cannot be covered by an authorisation granted down the supply chain to Company B. Company A needs to have his use (the formulation) covered by a separate authorisation granted directly to him or to an actor up his supply chain (for instance the manufacturer of the Annex XIV substance). Note that distributors who only store the Annex XIV substance before placing it on the market cannot be considered as Downstream Users in the context of Article 56(1)(e), see Q&A 577 for more details.

See supply chain coverage diagram

I use an Annex XIV substance in a mixture. Should the information in the application be presented for the mixture or for the substance?

Information presented should be for the substance as the authorisation is (or is not) granted for a given substance.
See also FAQ ID=130 in Frequently Asked Questions about REACH.

May an authorisation be reviewed before the expiry of the period for which it has been granted for?

Yes. An authorisation can be reviewed before the expiry of the review period. REACH Art 61(2) specifies that: "Authorisations may be reviewed at any time if: (a) the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio- economic impact; or (b) new information on possible substitutes becomes available"". In this case, the Commission shall set a reasonable deadline by which the holder(s) of the authorisation may submit further information necessary for the review and indicate by when it (i.e. the Commission) will take a final decision.

What rights does the applicant have to challenge the decision of the Commission?

An applicant has the right to contest the decision of the Commission before the General Court.

Who will enforce the authorisation decisions and how?

The enforcement of REACH is a responsibility of each EU Member State, as well as the members of the EEA (Norway, Iceland and Liechtenstein). They must ensure that there is an official system of controls and lay down legislation specifying penalties for non-compliance with the provisions of REACH. See also FAQ ID=3 in Frequently Asked Questions about REACH.

What other key sources of information might ECHA use when evaluating Applications for authorisation?

All information available to ECHA could be used; for instance, CLP notifications, dossier evaluation results or any relevant information arising from the public consultation on alternatives.

When will I receive the decision of the Commission after I have submitted my application?

It will take about 2 years. Article 64 of the REACH Regulation gives many details. Below we give an overall description of the timelines. Once you have submitted the application it takes about 2-3 months for its processing and for the application fee to be received by ECHA. The Committees will prepare their draft opinions within 10 months from that date of receipt of the fee. The applicant can comment on the draft opinions within 2 months before the Committees adopt their final opinions. This will take 2 months. Some weeks are also reserved for sending and receiving the draft opinion. Thus, it takes about 17-18 months for the applicant to receive the final opinions from the date it had submitted the application. ECHA will publish the opinions on its website and send them to the Commission, the Member States and the applicant. A final decision granting or refusing the authorisation shall be taken via a 'comitology' procedure (see the "examination procedure" referred to in Article 5 of Regulation (EU) No 182/2011). All in all, it would normally take about 6 months to have the final decision from the publication of the opinions of the Scientific Committees on ECHA's website.

Are there clear criteria on which the opinions will be based and which could provide more certainty about the outcome of the application?

The criteria for granting an authorisation are clearly defined in Art. 60 of REACH: under the "adequate control route" (Art. 60(2)) an application shall be granted if the risk to human health and the environment from the use of the substance arising from the intrinsic properties specified in Annex XIV is adequately controlled.

 Under the "socio-economic route" (Art. 60(4)), an authorisation may be granted if it is shown that (i) the socio-economic benefits outweigh the risk to human health and the environment from the use of the substance and (ii) there is no suitable alternative substances or technologies.

The factors to be taken into account for assessing the availability of suitable alternatives are described in Art. 60(5) and in the Guidance on Applications for Authorisation.

Also, two important documents describe how RAC and SEAC intend to evaluate the applications:

As a downstream user relying on an authorisation granted to a manufacturer/importer up in my supply chain, will I receive a unique authorisation number for all the authorised uses?

No. An authorisation number is unique to each combination of [applicant-substance-use applied for]. If the downstream user is himself an applicant (in either single or joint application), he will get its own authorisation number(s) related to the authorised use(s). If the downstream user is not an applicant but that he relies on an authorisation granted to a manufacturer/importer up his supply chain for his uses, the downstream user will not receive his own authorisation number(s) but he will be informed by his supplier about the authorisation number (which should be mentioned at least on the label of the product). 

Can restrictions be applied on the use of Annex XIV substances in articles?

Yes. After the sunset date, according to Article 69(2), ECHA has the obligation to consider the risks related to the corresponding Annex XIV substance in articles and possibly apply the restriction procedure if the risk to human health or the environment is not adequately controlled. In this case, the Agency shall prepare a dossier which conforms to the requirements of Annex XV. This assessment will have to be done for each Annex XIV substance after its corresponding sunset date.

In addition, Member States or ECHA (on request from the Commission) may propose a restriction at any time on the use of any substance (including SVHCs) in articles if the risks arising from the use of these articles are not properly controlled.
 

Can an Only Representative apply for an authorisation on behalf of several companies located outside the EU?

Yes. The non-EU companies can also be located in different jurisdictions. The application fee will be assessed for each non-EU legal entity the Only Representative represents in the application.

Only Representatives have to sign-up in REACH-IT for each non-EU company they represent and submit the relevant IUCLID dossier using the appropriate accounts. It is not possible to use the same Legal Entity Object (having the same company UUID) for multiple accounts, but it is possible to use the same company identification information (name, VAT, etc.). Similarly as for Registration, Only Representatives must indicate in the "company size" field of REACH-IT the size of the non-EU company they are representing. In the determination of their size, linked and partner enterprises to the company the Only Representative represents should also be taken into account.

In addition, Only Representatives are advised to attach clear documentation of their appointment in their application (for instance, a copy of the appointment) in the field "Assignment from non EU manufacturer" of the IUCLID file (IUCLID section 1.7). Only Representatives are also advised to indicate the list of the importers' names covered by the application in the field "Other importers".

For more details:

 
Will ECHA inform the applicant if it has accepted the justifications for claiming certain information confidential?

No. ECHA will not inform the applicant of its decision on all the confidentiality claims in the application for authorisation.

On the other hand, there may be situations where ECHA finds it necessary to make publicly available information that the applicant claimed confidential. In such cases ECHA will inform the applicant of this decision and allow him to respond appropriately.

An example of such a situation is if insufficient information falling under the broad information of uses is given in the public parts of the application for authorisation ("public versions" of the assessment reports, i.e. the Chemical Safety Report, Analysis of alternatives, Socio-economic analysis, Substitution plan or their annexes). In such a case ECHA has reserved the right under Article 64(2) of REACH to supplement the broad information package for the public consultation on alternatives with the necessary information from the "complete versions" of these assessment reports with the aim to make the public consultation meaningful. ECHA gives the applicant the opportunity to comment its proposal for broad information of uses before the final version is issued and published.

See also Q&A 590, 592 and 594.
How is the time-limited review period set in authorisation decisions?

ECHA has consulted the services of the European Commission on this. As a general principle, if you apply for authorisation before the latest application date, the review period would be counted from the sunset date. In practice, this means that applying early would not shorten your time for placing on the market and/or using the substance after the sunset date as compared to applying closer to the latest application date.

If you apply for authorisation after the latest application date, the placing on the market and use of the substance will no longer be allowed as from the sunset date, unless a decision granting an authorisation has been adopted by then. If the decision is adopted before the sunset date, the review period would in principle be counted from the sunset date. If a decision is adopted after the sunset date, the review period would be counted from the date of entry into force of the decision

I am a downstream user of an Annex XIV substance and the European Commission has not yet decided on the application for authorisation submitted by a company up my supply chain covering my use. The sunset date of the substance has passed.
a) Do I have to stop using the substance?
b) Do I have to notify my use to ECHA?

a) It depends.
You do not have to stop if the application made up your supply chain has been submitted before the substance’s latest application date. In this case, you can continue using the substance after its sunset date, awaiting for the European Commission’s decision.
You have to stop if the authorisation application has been submitted after the substance’s latest application date. You can restart using the substance only if the European Commission decides to grant an authorisation for your use. 

b) Not yet. As long as the European Commission’s decision on the authorisation application covering your use is pending, you cannot notify your use to ECHA. The notification of authorised uses is possible only after an authorisation has been granted. Once the decision to grant an authorisation has been adopted, you then need to submit a downstream user notification of your authorised use (Article 66 of REACH) to ECHA within three months from the first delivery of the substance (see also Q&A 1441).

 

I am a downstream user of an Annex XIV substance and the European Commission has decided to grant an authorisation for my use to a company up my supply chain. Do I have to notify my use to ECHA?

Yes. If you rely on an authorisation granted to an actor up your supply chain, you must notify your authorised use to ECHA. You must submit your notification within three months from the first delivery of the substance following issuing of the authorisation decision. Your notification needs to refer to the relevant authorisation number(s). Authorisation numbers are indicated on the label of the product and the safety data sheet you receive from your supplier. As they are use-specific, you need to select the specific authorisation number(s) which correspond to your use. Authorisation numbers have the format 'REACH/x/x/x' (see also Q&A 750).

Naturally, you need to comply with the conditions of the authorisation, which should be communicated to you by your supplier in the safety data sheet.

For further information on the downstream user notification for authorised uses (Article 66 of REACH), see: 

https://echa.europa.eu/support/dossier-submission-tools/reach-it/downstream-user-authorised-use 

https://newsletter.echa.europa.eu/home/-/newsletter/entry/4_15_downstream-users-notify-echa-if-you-use-an-authorised-substance

 

b) Scope

Does the use of a substance listed on Annex XIV require an authorisation when contained in a mixture at a concentration below that specified in Article 56(6) (a) and (b) of REACH?

Authorisation is required for the use of a substance included in Annex XIV of REACH, either on its own or in a mixture. If a substance is used as such, this is a use of the substance on its own, and the exemptions in Article 56(6) (a) and (b) of REACH cannot be applied. If the substance is used in a mixture, then the aforementioned exemptions may be applied. These exemptions apply to SVHCs meeting the criteria of points (d), (e) and (f) of Article 57 of REACH below a concentration limit of 0.1 % w/w, and for all other substances below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous.

Does the exemption from the authorisation requirement for substances in mixtures (Article 56(6)b of REACH) depend on their classification in any hazard class or only the hazard classes for which the substance was included in the authorisation list?

The authorisation requirement does not apply to the use of CMR substances when they are present in mixtures below the concentration limits specified in Article 11(3) of the CLP Regulation, which result in the classification of the mixture as hazardous (Article 56(6)b of REACH).

Only the hazard class (or hazard classes) which specifically led to inclusion of the substance in the authorisation list should be taken into account.

The basis for this is to target the intrinsic properties of highest concern, which is the objective of the authorisation process.

This is reflected in the legal provisions of REACH:

  • Article 62(4), which requires an application for authorisation only for the hazard class given in the authorisation list, and
  • Article 60(2), which limits the assessment of a request for authorisation to the hazard class given in the authorisation list under the adequate control route.

 

Is there any tonnage threshold below which Annex XIV substances are exempted from the authorisation requirement?

No. There is no tonnage threshold below which (the placing on the market for) a use of an Annex XIV substance is exempted from the authorisation requirement.

Does the authorisation requirement apply to the use of substances in articles?
No. The placing on the market or the use of an article which contains an Annex XIV substance is not subject to the authorisation requirement. However, if not specifically exempted otherwise, the incorporation of an Annex XIV substance into an article is a use which is subject to the authorisation requirement. Moreover, the Chemical Safety Report of an application for authorisation for a given substance should cover the whole substance service-life for the "use(s) applied for", including the service life of articles and the waste stage (see Article 62(4)(d) and Annex I (5.1.2) and (5.2.2) of REACH).
 
Other legal requirements also apply to substances of the Candidate List present in articles, such as communication obligations along the supply chain and notification to ECHA:
 
Article 33(1) of REACH requires that a supplier of articles containing a SVHC included in the Candidate List for authorisation in a concentration above 0.1% (w/w) has to provide relevant safety information to the recipients of these articles. Upon request of a consumer, the same supplier has to provide relevant safety information about the SVHC available to him also to this consumer (Article 33(2) of REACH). This obligation applies irrespective of the tonnage of the substance used and also applies to imported articles. Importers and producers of articles have to, under certain conditions, notify to ECHA if their articles contain Candidate List substances (as per Article 7 of REACH).
For more information, see: 
 
Does the authorisation requirement apply to a substance in Annex XIV that is present as an impurity in another substance or mixture?

The authorisation requirement applies to the placing on the market and use of a substance on its own as listed in Annex XIV. Therefore, it usually does not apply if the Annex XIV substance is only an impurity or additive or constituent of another substance, unless this is specified in the Annex XIV entry (e.g. substance W and substances X, Y and Z containing substance W in a concentration ≥ x %) or the other substance is also listed in Annex XIV.If a substance listed in Annex XIV is included as a component in a mixture, the authorisation requirement applies for this use (i.e. the formulation of the mixture). Further, the placing on the market and use of such mixtures require authorisation, unless the Annex XIV substance is present in the mixture below the concentration limits set out in REACH Article 56(6).
See also: Guidance for identification and naming of substances under REACH (link to http://echa.europa.eu/documents/10162/13643/substance_id_en.pdf)

Are uses of recovered substances exempted from the authorisation requirement?

No. Uses of recovered substances are not exempted from the authorisation requirement. As in case of use(s) of any other Annex XIV substance, use(s) of a recovered substance whose identifiers correspond to those of an entry in the Annex XIV of REACH is subject to the authorisation requirement, unless the use of the substance is specifically exempted otherwise.
See also: Guidance on waste and recovered substances http://echa.europa.eu/documents/10162/13632/waste_recovered_en.pdf

Does the exemption for the use of Annex XIV substances in scientific research and development (SRD) under Article 56(3) of REACH also apply to analytical activities such as monitoring and quality control?

Yes. Under Article 3(23) of REACH, scientific research and development means any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year. Thus, the use of an Annex XIV substance in analysis is exempted from authorisation under Article 56(3) if the substance is used, on its own or in a mixture, in analytical activities such as monitoring and quality control where these activities are carried out under controlled conditions and in a volume not exceeding one tonne per year and per legal entity. 

The exemption applies to the use of an Annex XIV substance when it is required as part of an analytical method for the measurement of another substance or property (e.g. used as an extraction solvent or reagent, or to validate the technical specification or performance of a product) and the analysis of the Annex XIV substance itself (e.g. for quality or process control). Where these conditions are met, there is no need to apply for an authorisation for this use or to include this task as a working contributing scenario (i.e. PROC 15) in an application for authorisation. 

This exemption applies irrespective of where the analysis is performed i.e. on-site or off-site facilities. However, this exemption does not cover sampling activities (see Q&A 1153).

Does the authorisation requirement apply to a substance listed in Annex XIV of REACH which is used exclusively as an analytical reagent or in routine analysis?
If the substance is used for monitoring or quality control purposes under controlled conditions in quantities below 1 tonne per year, it falls under Article 56(3) of REACH, which exempts substances used in scientific research and development from the authorisation requirement.
Article 2(5), subparagraphs (a) and (b), and Article 56 subparagraphs (4)((a), (b), and (c)) and (5)((a) and (b)) of REACH exempt from the authorisation requirement a number of uses in products (medicinal products, food or feedingstuffs, plant protection products, biocidal products, motor fuels, cosmetic products and food contact materials, respectively) within the scope of, or covered by, the sector-specific Union legislation specified in those provisions. 1. Do these exemptions cover the incorporation of the Annex XIV substance into the product during the manufacturing process? 2. Do these exemptions also cover the life-cycle steps (such as formulation) preceding the incorporation of the substance into the product in question?
  1. Yes, these exemptions cover the incorporation of a substance into the product during the manufacturing process.
  2. Yes, the uses of a substance upstream preceding an exempted end-use are also exempted but only in the volumes ending up in the exempted end-use.  It should be noted that, with regard to uses in cosmetic products and in food contact materials, the exemption only applies when the intrinsic properties specified in Annex XIV for the substance in question concern hazards to human health.
 
Article 56 (4)(d) of REACH contains an exemption from the authorisation requirement for the use as fuels in closed systems. Does this exemption also cover the life-cycle steps (such as formulation) preceding this end-use?

Yes, the uses of a substance upstream, preceding "use as fuels in closed systems", are also exempted under the condition that the control of the risks – i.e., use in closed systems – is also pursued in the upstream life-cycle steps preceding the end-use as a fuel.

Does an application for authorisation for the use of a substance in a medical device regulated by the sector-specific legislation referred to in Article 60(2) 2nd subparagraph of REACH have to be submitted for a substance for which Annex XIV specifies human health hazards only? Does this exemption cover the incorporation of the Annex XIV substance into the product during the manufacturing process? If so, are the life-cycle steps preceding the incorporation of the substance in the medical device subject to authorisation?

Pursuant to Articles 60(2) and 62(6) of REACH, an application for authorisation is not required for a substance used in a medical device regulated under Directives 90/385/EEC, 93/42/EEC or 98/79/EC if that substance has been identified in Annex XIV for human health concerns only.   Nor is an application required in such cases for the incorporation of the substance into the medical device during the manufacturing process or for the uses and corresponding volumes of that substance upstream preceding the end-use.

Article 56 (3) of REACH exempts from the authorisation requirement the use of a substance in scientific research and development (SRD). Does this exemption also cover the life-cycle steps (such as formulation) preceding the end-use in SRD?
Yes, the uses of a substance upstream preceding an exempted end-use in SRD are also exempted in quantities of the substance ending up in SRD (i.e. under 1 t/y per user) subject to what is set out below.
 
Article 3(23) defines SRD as any scientific experimentation, analysis or chemical research to be carried out "under controlled conditions" and "in a volume less than one tonne per year". Therefore, the exemption in Article 56 (3) covers an activity which is delimited by a certain level of control of risks– i.e., use under controlled conditions and in a volume less than 1 tonne per year. It also applies to the upstream life-cycle stages of the substance preceding its end-use in SRD, for the volumes ending up in that end-use and which, during the upstream life-cycle, are handled and/or used under controlled conditions, even if the volume handled and/or used during the upstream life-cycle stages exceeds 1 tonne per year.

In case of any contradictions between the position expressed in this Q&A and the positions expressed previously by ECHA in the RCOM of 20 December 2011, the position expressed in this Q&A should be considered as the current understanding of the law. It takes precedence over any other views communicated previously by ECHA on this issue.
 
Is the manufacture of a substance, whether for export or placing on the EU market, subject to the authorisation requirement?

The manufacture of a substance is not subject to the authorisation requirement. After a substance has been manufactured it may have to be handled before it is exported or placed on the EU market. Operations which are necessary for the handling of a substance on its own in the manufacturing for export or placing on the EU market are considered to be part of the manufacturing stage (e.g. filling into appropriate containers, storage, addition of stabiliser, dilution to a safer concentration -if necessary for transport safety-), but not other uses such as the formulation of a mixture or incorporation of the substance into articles. The formulation of a mixture or incorporation of the substance into articles are considered "uses" within the meaning of Title VII of REACH and are subject to the authorisation requirement whether or not the mixture or articles will be exported or placed on the EU market. 

Does the exemption for the use of Annex XIV substances in scientific research and development under Article 56(3) of REACH also apply to sampling activities for further quality control analysis?

No. When a sample containing an Annex XIV substance is taken from a production line for further analysis the sampling activity shall be described and assessed e.g. in a worker contributing scenario that is part of the application for authorisation. However, activities considered to form part of the use of the sample in performing analytical activities can benefit from the exemption under Article 56(3) of REACH. See also Q&A 585.

Does the exemption for the use of Annex XIV substances in scientific research and development (SRD) under Article 56(3) of REACH also apply to analytical activities using in vitro diagnostic (IVD) medical devices (as defined in Directive 98/79/EC) at a laboratory scale?

Yes. The use of an Annex XIV substance when it is required, on its own or in a mixture, as part of an in vitro diagnostic (IVD) method (e.g. in a reagent, calibrator, control material or kit) is considered as scientific research and development and is therefore exempted from authorisation requirements if this activity is carried out under controlled conditions and in a volume not exceeding one tonne per year per legal entity (see Q&A 585). 

Annex XIV substances may be required to provide a range of functions during IVD analysis, including: to remove impurities, to prevent undesired reactions that would lead to false positive results, to stabilise or solubilise proteins during analysis, to inactivate viruses prior to analysis.

The exemption covers also IVD medical devices for veterinary and animal health purposes.

 

 

 

Does the exemption for the use of Annex XIV substances in scientific research and development (SRD) under Article 56(3) of REACH also apply to the use of an Annex XIV substance in upstream life-cycle stages to produce in vitro diagnostic (IVD) medical devices?

It depends. See the more general Q&As 1498 and 1030, as well as Q&A 1442.

For instance, the incorporation of an Annex XIV substance into an IVD medical device which is an article is not exempted under Article 56(3) REACH. Similarly, the use of an Annex XIV substance in upstream life-cycle stages to produce IVD medical devices which are not articles (e.g. reagents, calibrator, control material or kits) and where the Annex XIV substance is not incorporated into the IVD device is not exempted under Article 56(3) REACH. An example of the latter is the use of an Annex XIV substance to lyse cell membranes during the purification of antibodies that are subsequently used in an IVD medical device which is not an article: that use would require an authorisation. 

 

Does the exemption for the use of Annex XIV substances in scientific research and development (SRD) under Article 56(3) REACH also apply to Annex XIV substances used together with or incorporated in SRD articles?
It depends. The exemption applies, for example, to an Annex XIV substance used together with (but not becoming an integral part of) an article both produced for SRD purposes (e.g. reagent used together with an analytical apparatus). However, the exemption does not apply to an Annex XIV substance which is integrated in (i.e. becoming an integral part of) an article produced for SRD or non-SRD purposes (e.g. mercury in thermometers). Similarly, the exemption does not apply to an Annex XIV substance used to produce an SRD article if the substance is not intentionally incorporated into the SRD article (e.g. used as processing aid or solvent during the manufacturing of the SRD article).
c) Format and content of authorisation

What is the format for authorisation applications?

Application for authorisation dossiers shall consist in an IUCLID file, to which a series of specific documents are attached. For the purpose of an application for authorisation, the latest version of IUCLID should be used. Formats for these attachments are provided by ECHA on its website

How can an applicant submit an application to ECHA?

Authorisation application dossiers shall be submitted electronically via REACH-IT. See (http://echa.europa.eu/applying-for-authorisation)

In which language shall I submit my application for authorisation to ECHA?

The whole application can be submitted in any single official EU language. For example, you can submit the whole application in English. However, you cannot submit an application where most of the documents are in English and rest in another language, For details, see question 129.

What will ECHA do if it receives applications that contain documents in more than one official EU language?

ECHA would consider those parts of the Application that are not in the main language as "not received". These documents could be essential for conformity of the application under Article 62 of REACH. If so, the Committees would request the applicant to submit an update of these documents in the main language. If the applicant fails to submit the translations, the Committees would not consider the application to be in conformity with the requirements of Article 62.

What is meant by the "Broad Information on Uses" package and what does it contain?

The Broad Information on Uses (BIU) of the Annex XIV substance refers to a "brief wording" containing:

- information based on the name of the use applied for,
- the use descriptors and function, and
- key information on the conditions of use.

In addition, the BIU contains the following documents:

- the public version of the Analysis of alternatives,
- the public version of the Substitution Plan, if provided in the application,
- the public version of the Socio Economic Analysis, if provided in the application, and
- the public version of sections 9 ("Exposure assessment") and 10 ("Risk characterisation") of the Chemical Safety Report (CSR) covering the use applied for.

For further details and example, see: http://echa.europa.eu/documents/10162/13555/public_information_afa_en.pdf

Will the applicant's name be made public?

Yes. The applicant's name will normally be made public as part of the Broad information Use during the public consultation on alternatives.

How can I provide in my application a "complete" and a "public" version of sections 9 ("Exposure assessment") and 10 ("Risk characterisation") of the Chemical Safety Report (CSR) covering the uses applied for?

Include the complete versions of sections 9 and 10 in your Chemical Safety Report (CSR) and attach the CSR to section 13 of IUCLID (naming it for instance "CSR.pdf").

Attach a public version of sections 9 and 10 naming it clearly (e.g. "Public_version_of_CSR sec9-10.pdf") and attach it as a separate document in section 13 of IUCLID.

If all the information contained in sections 9 and 10 can be made public, then these two sections will be published as they are provided in the CSR.

Do I need to update my Chemical Safety Report (CSR)?

If you (as the applicant) have already registered the Annex XIV substance, the CSR prepared for registration purposes should be the basis for the preparation of the CSR needed in an application for authorisation. However, it is likely that it needs to be updated and adapted to the authorisation context (e.g. regarding the refinement of uses, emissions and exposures, the overall quality of the CSR, etc). When submitting your application you can attach a version of your CSR specifically developed for authorisation. You can use this opportunity in cases, where you may wish to provide – for the authorisation purposes –  only an extract of the latest updated CSR submitted in the registration process. This updated CSR would contain only those parts that are relevant for the authorisation application, but developed in more detail.

Or you can simply refer to the CSR provided in your registration dossier. In the latter case you should – if necessary – update your CSR before you submit your application to ECHA. If you develop a specific CSR for authorisation, you should be aware that as a rule the information contained in the CSR submitted in an authorisation application should be in the CSR provided in the registration dossier.

After the sunset date the applicant will need to update the CSR submitted in the registration in order to remove all uses for which he has not applied for authorisation.

Following the authorisation decision taken by the Commission, the Applicant may also need to further update the CSR submitted in his registration.

How can an applicant provide information in its application which should not be made publicly available?

Applicants can provide information which should not be made public in the "complete versions" of the assessment reports (Chemical Safety Report, Analysis of Alternatives, Substitution Plan, Socio-Economic Analysis). Formats and instructions are available under the "Preparing Applications for authorisation" page (http://echa.europa.eu/applying-for-authorisation/preparing-applications-for-authorisation).

Applicants need to make "public versions" of these "complete versions". In "public versions"  the applicants need to blank out confidential business information. The "public versions" will be published on ECHA's website during public consultation on alternatives. Applicants need to provide solid justifications as to why the information which has been blanked out should not be made public.

What is a joint application?

A joint application is an application made and submitted simultaneously by a group of applicants (i.e. the submitting applicant and the co-applicants). The submitting applicant shall generate the list of co-applicants participating in the application and indicate the applicant-substance-use combinations. The co-applicants then need to confirm their participation to ECHA before the submitting applicant uploads the application.

Is a joint application easier to submit and manage than separate applications?

Due to the possible complexity and technical issues of joint applications, ECHA recommends to prepare and submit a joint application when (i) all co-applicants of the group apply for all uses in the joint application, and (ii) the co-applicants have agreed on a way to share all the information provided in the application.

In complex cases, it may be preferable for each applicant to submit their own application separately. The applicants can cooperate during the preparation of their applications. For details, see the manual ‘How to prepare an application for authorisation manual’.https://echa.europa.eu/manuals, Application for Authorisation Guidance (Appendix 2) and the presentations "Description of uses for authorisation / Broad Information on Uses" and "Joint versus Individual applications" for additional information.

Can an additional legal entity join a group of applicants after the submission of a joint application?

No. In contrast with Joint Registrations, an additional legal entity cannot join the group of applicants which have already submitted a joint application for authorisation.

What is a subsequent application?

An applicant may submit a subsequent application in which he can refer to appropriate parts of an application previously submitted for a use of a substance, provided that the subsequent applicant has permission from the previous applicant(s) to refer to these parts. Furthermore, the subsequent applicant shall update the information taken over from the original application as necessary. This subsequent application will be processed and evaluated on its own merits.

How will ECHA communicate with the applicant once an application has been submitted?

Via REACH-IT and the secured webforms. However, for organisational and practical issues, emails can be used.

I consider that the substance that I will apply for has a threshold. What if RAC disagrees with my assessment?
RAC intends to develop "reference DNELs" and "reference dose response relationships" for substances that have been listed in Annex XIV. The intention is to make these available before the latest application date has expired (see Q&A 752).
 
If you disagree with RAC's view you can justify this in your application. RAC will evaluate this during the opinion making process.
 
If RAC has not made the "reference DNELs" or ""reference dose response relationships" available before the latest application date it will do so during the opinion making. In any case, you and RAC will need to clarify the possible scientific issues relating to the thresholdness of the substance during the opinion making process.
 
If a threshold cannot be demonstrated, it is not possible to apply based on Article 60(2) in relation to adequate control. However, the application can be evaluated based on Article 60(4). In this case ECHA strongly recommends that the application contains a socio-economic analysis(see Q&A 617).
In a joint application, can confidential information from a joint applicant made secret to the other applicants?
No. The submitting applicant (i.e. the applicant submitting the joint application on behalf of the group of joint applicants) has access to all the information contained in the application. Furthermore, during opinion making confidential information is likely to be referred to within the group of joint applicants; for instance, in ECHA's messages in REACH-IT all co-applicants receive a copy of the message. 
 
ECHA will treat a joint application as a whole and has no possibility to make any special arrangements to accommodate confidentiality issues between joint applicants. 
 
See also Q&A 596.
Can I submit a single application covering several substances?

Yes, if they form a group. The possibility to cover more than one substance in the same application is limited to substances that meet the definition of a group of substances as stated in Section 1(5) of Annex XI of the REACH Regulation. In all other cases, you have to submit a separate application for each substance. See Appendix I of the Guidance on the preparation of an application for authorisation on substance grouping.

The manual requires us to attach a concordance table to our application. Is there a template?

To further simplify the preparation of applications for authorisation, ECHA no longer requires concordance tables. Any reference to the concordance table in the manuals can therefore be ignored.

When commenting the draft opinions of RAC and SEAC, can I submit additional or new data that I had not provided when the committees were preparing them?

When reading the Committees' draft opinions you may have noticed misinterpretations, misunderstandings or even errors that need to be addressed in the draft opinions. ECHA encourages you to provide all the necessary clarifications with the relevant supporting evidence during the commenting period. However, the Committees will only take into account new data or information (e.g. new measurements, figures) that are related to such misinterpretations, misunderstandings or errors noted by the applicant. It is the obligation of the applicant to provide the necessary relevant data at the time of the initial submission of the application or in response to earlier requests from the Committees.

d) Authorisation fees and invoicing

How is the fee for an application for an authorisation calculated?

Several scenarios can be envisaged: A base fee is payable, which covers one substance and one use. An additional fee applies for each additional use and substance. No additional fee for additional applicant(s) is levied, though. However, the levels of the base fee and of the additional fees per use and substance depend on the size of the largest company that is party to the application - .i.e. if in joint applications companies are of a different size, the highest applicable fee will be levied.  

For example, in the case of an application submitted by four parties with ten three uses and two substances in total, the relevant fee will be the base fee applicable to the largest applicant + three additional applicant fees + nine two additional use fees applicable to the largest applicant + one additional substance fee applicable to the largest applicant.

The table below shows four examples of calculated fee for applications for a single substance where the (largest) applicant is a large company.

Table: Fees depend on the number of uses, not applicants

Examples A B C D
Applicants 1 2 1 2
Uses 1 1 2 2
Fee €54 100 €54 100 €102 790 €102 790

The possibility to cover more than one substance in the same application is limited to substances that meet the definition of a group of substances as defined in Section 1(5) of Annex XI of the REACH Regulation. In all other cases, a separate application must be submitted for each substance.

Further information: ECHA Fee Calculator: a tool provided by ECHA to estimate the possible amount of a fee related to a given application for authorisation.

On the REACH Fee regulation: see more information on REACH Legislation -page and Commission Implementing Regulation (EU) 2018/895 of 22 June 2018

 

Application for one applicant and one substance only

If you submit an application for an authorisation on your own, you will have to pay a base fee. That fee covers one use and one substance. If you need to apply for authorisation for more uses, you will need to add an additional fee for each additional use you want to cover. Thus, if your application covers three uses, the fee that you will have to pay is the sum of the basic fee + two additional use fees. The level of the base fee and the additional fees depend on the size of your company; reduced fees apply if you are a micro, small, or medium-sized enterprise.

How will ECHA calculate the fee and send the invoice in the case of joint applications?

ECHA will calculate the fee based on the Fee Regulation. It has made available a Fee Calculator to help the applicants to know in advance the amount that they would expect to pay.

ECHA will send the invoice always to the legal person that submitted the application. Thus, in a joint application ECHA will send the invoice to that applicant that submitted the application. It is then up to this applicant to split the invoice according to the agreement that the applicants have made between themselves. For clarity, ECHA is not in a position to send separate invoices to each of the parties covered by the application. 

How will the applications be invoiced and paid?

ECHA sends the applicant an invoice in about 8 weeks after the submission.  

The applicant has 14 calendar days to pay the invoice with a possibility to extend it by another 7 calendar days. Thus, all in all the applicant is given 21 days to pay the invoice from the date it received the invoice.

If the payment is not made by the extended payment due date, the application for authorisation will be considered as not received by ECHA. In this case the application is not processed further. The only way to proceed is to re-submit the application.

The Fee Regulation (EC No 340/2008) related to the fees for Applications for authorisation has been amended by Commission Implementing Regulation (EU) No 254/2013 of 20 March 2013. Updated articles 8(2) and 9(2) state that "the Agency shall issue one invoice covering the base fee and any applicable additional fees". How will these additional fees be levied?

The necessity to impose an additional fee will reflect ECHA's workload associated with processing and evaluating the application. The calculation of the base fee and any applicable additional fees is described in Q&A 600. An application would lead to additional workload if the number of ‘uses applied for' and/or exposure scenarios is greater than one. One "use applied for" shall be covered by at least one exposure scenario. However, the number of uses vs the number of exposure scenarios might not be identical. Thus, in order to reflect the additional workload, ECHA calculates the fee based on the highest number of uses vs. exposure scenarios.

Example 1: Iif you apply for two uses that are covered together in your Chemical Safety Report by one generic exposure scenario, ECHA will calculate the invoice based on two uses.

Example 2: If you apply for two uses which are covered by three different exposure scenarios, ECHA will estimate whether the evaluation of the additional exposure scenario increases ECHA's workload and whether the fee can be based on three uses.

Is there a fee for confidentiality claims in Applications for authorisation?

No.

Will ECHA consider one exposure scenario for article service life as equivalent to one use for determining the fee?

No. Currently ECHA will not impose a fee for an exposure scenario covering an article service life. ECHA needs to gain experience with the first applications for authorisations. ECHA reserves its right to re-evaluate this approach if, based on the experience gained with handling this type of exposure scenarios in the context of an Applications for Authorisation, ECHA concludes that the associated workload warrants a fee. It is also possible that a fee may be imposed for instance, in conjunction with a review of the Fee Regulation in the future.

e) Preparing for authorisation application

What is the purpose of the pre-submission information sessions?

Pre-submission information sessions give an opportunity for future applicants to clarify regulatory and procedural aspects of the authorisation application process, and for ECHA to have a better understanding of the practical issues related to Applications for authorisation.
For further details see ECHA's Support webpage on pre-submission information sessions (link to: http://echa.europa.eu/applying-for-authorisation/pre-submission-information-sessions).

When and how can I request a pre-submission information sessions?

You can make a request a pre-submission information session either when notifying ECHA of your intention to submit an application for authorisation, or later. You should nevertheless send your request for a pre-submission information session at least 8 months before the planned date for the submission of your application for authorisation. Although you can still notify less than 8 months in advance of the submission of your application, this may have an impact on ECHA's availability to organise a pre-submission information session for your company. Please bear in mind the PSIS should take place at least 2 months after the meeting request and that you probably would like to have sufficient time after the PSIS to potentially further work on your application before submitting it to ECHA.

Requests for pre-submission information sessions are made via a secure web form, available on ECHA's website. For further details see ECHA's Support webpage on pre-submission information sessions (link to: http://echa.europa.eu/applying-for-authorisation/pre-submission-information-sessions).

How can I have access to the Lead Registrant's Chemical Safety Report (CSR) data if he is not taking part in the application for authorisation? What can I do if the data owner refuses to give me access to its data? Can I use the information available on ECHA's dissemination website?

A CSR has to be submitted as part of the application. This CSR can be (i) the applicant's own CSR for authorisation, or (ii) a reference to CSR submitted by the same applicant for registration, or (iii) a reference to CSR of a previous applicant (case of subsequent applications for authorisation). If the applicant for authorisation is a Downstream User (i.e. not a registrant) and he generates his own CSR for the authorisation, this CSR can be based on updated information from the registrant's CSR as long as he has the right to use the information from the respective data owners.

However, data sharing obligations as specified under Art 30 of REACH do not apply for authorisation. The reproduction or further distribution of information from Registration Dossiers and Notifications to the C&L Inventory which are published on ECHA's dissemination website may be subject to copyright protection. Furthermore, the use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner. The Agency does not take responsibility for any copyright or other infringements that may be caused by using the information.

Potential applicants are reminded that they shall ensure that they have adequate rights to submit this information to the Agency and acknowledge that this information can be used for the purpose of the application for authorisation.

See also question 916

Will a pre-submission information session (PSIS) be available for the whole group of applicants participating in a joint application or will there be a separate PSIS for each co-applicant?

In joint applications, only one PSIS will be available, and this session is for the group of applicants as a whole. Due to the limited availability of places for the PSIS, it is for the group of applicants to decide who would be the most appropriate to represent them in the session.

How should I develop the ‘uses applied for' and exposure scenarios in my application?

The description of the ‘uses applied for' and of the related exposure scenarios is key step in the preparation of an application for authorisation. The concept of "use applied for" in the context of applications for authorisation might significantly differ from what industrial actors usually understand by a "use" in their day-to-day practice. The ‘use applied for' description, scope and level of details are not only related to the risks linked to the exposure/release of the Annex XIV substance but also to the analysis of alternatives and, where relevant, to the socio-economic analysis and substitution plan. The following documents describe this issue in more details:

 
Which DNEL should I use?

The demonstration of adequate control or minimisation of the risks should be made in the Chemical Safety Report (CSR) of the application for authorisation. REACH Annex I defines the Derived No-Effect Level (DNEL), i.e. the level of exposure above which humans should not be exposed and the way the risk characterisation for the human population should be performed, based on the DNEL (if a DNEL can be determined). DNELs derived according to the ECHA guidance are therefore the reference data for the demonstration of adequate control. 

It should be noted that the Committee for Risk Assessment (RAC) has derived reference DNELs for  some substances on Annex XIV and intends to continue doing so for other Annex XIV substances. 

For more details, see:

How many pages should an application contain?

An application for authorisation is not a matter of pages but rather how convincing the argumentation is. All the necessary information for the ECHA Committees for making their opinions and for the Commission to make its decision should be included in the application in a clear and convincing way. Overall in a well-argued application, strong or clear messages should not be diluted or obscured by lengthy text. Also you can consider using appendixes to provide additional, complementary information.

Would the application be in conformity according to Article 62(4)(d) of REACH if it took as a premise the ‘Reference DNEL' or ‘dose response relationship' adopted by RAC and published on ECHA's website?

Yes, as long as the application is in conformity with the rest of Article 62 and the applicant decides to use in his assessment the DNELs or dose response relationships derived by RAC for the intrinsic properties of the substance specified in Annex XIV. In this case the applicant does not need to provide the hazard data necessary to derive DNELs or dose response relationships.

See also Q&A 752 and 912

Do I need to include Part A in the Chemical Safety Report (CSR), when I submit it as part of my application for authorisation?

Yes, the Chemical Safety Report shall always include the "Part A" duly completed. Part A contains the Summary of Risk Management Measures and the declarations that these measures are implemented and communicated. See also Q&A 611.

f) Analysis of alternatives

Do I need to consider also Substances of Very High Concern (SVHC) in my Analysis of Alternatives?

Usually not. A suitable alternative should results in an overall reduction of risks to human health and the environment compared to the Annex XIV substance. An alternative substance having a similar (eco)toxicological profile to the Annex XIV substance (for instance a SVHC substance) is unlikely to meet the overall reduction of risks criterion. However, even if the alternative does not lead to an overall reduction of risk, this alternative substance should still be part of your analysis of alternatives but the conclusion regarding the overall reduction of risks should be relatively straightforward. As a consequence, you may consider whether a detailed analysis of its technical and economic feasibility is necessary in such a case.

How will the ECHA Committees (RAC and SEAC) take into account third parties' comments submitted during the public consultation on alternatives?

As a result of the eight-week public consultation both the "complete" and the "public" versions of the comments on the alternatives are made available to the Rapporteurs and the Committee members. The Rapporteurs will use this information as any other information during an evaluation process. The relevance, validity and reliability of the information will be assessed. The applicant will have a possibility to respond to the "public versions" of the comments. The Rapporteurs may pose follow-up questions to the third parties. They may also pose questions or require additional information from the applicant, as a result of the information provided by third parties.

What is the scope of the Analysis of Alternatives and the Socio-economic Analysis? The applicant's perspective or the society as a whole?

Both the applicant's and society's perspectives are relevant in the application. The applicant's perspective is relevant in the Analysis of Alternatives to assess how feasible it would be for the applicant to adopt any alternatives which are available to him. This would include the alternative of ceasing use of the substance altogether. This analysis can be used to identify the non-use scenario(s) which would pertain, if authorisation is not granted. The use and non-use scenarios should be assessed from society's perspective to provide an assessment of whether authorisation is justified from a social perspective or not, based on a comparison of the benefits of authorisation and the risks.

The applicant should undertake an Analysis of Alternatives as if they will be unable to use the substance in question beyond the sunset date, that is, as if their application for authorisation is not granted. Thus, the scope should be whatever the applicant would normally use when choosing alternative substances or technologies in his business. One qualification to this is that alternatives might be suggested through the public consultation of which the applicant was previously unaware or would not normally consider. He might wish, therefore, to extend the normal scope of his analysis in anticipation of this.

It is not possible to generalise about the exact scope of the socio-economic analysis, as this will vary on a case-by-case basis. The principle is that all factors should be incorporated to the extent that they might make a material difference to the conclusions. An iterative approach to developing the analysis, as well as consultation and input from socio-economic analysis experts, can be helpful in establishing the appropriate scope in any given situation.

More details in the presentations of the seminars on application for authorisation:

http://echa.europa.eu/addressing-chemicals-of-concern/authorisation/applications-for-authorisation/afa

I will submit an Analysis of Alternatives for a threshold substance. I have R&D activities to develop and implement safer alternatives that are neither suitable nor available yet. Can I submit a Substitution Plan with my application?

A Substitution Plan should be provided if suitable alternatives are available (cfr. Article 62(4f)). A Substitution Plan is a commitment to take the actions needed to substitute the Annex XIV substance with a suitable alternative substance or technology within a specified timetable. If you conclude that the alternatives you have identified are neither suitable nor available yet, you should not submit a separate Substitution Plan. You should rather include all the relevant information on R&D activities in your Analysis of Alternatives. Refer to the Guidance on Application for Authorisation for more information.

Is it appropriate to provide a socio-economic analysis under the adequate control route?

There is no requirement to submit a socio-economic analysis when submitting an application for authorisation under the adequate control route. However, ECHA recommends that a targeted socio-economic analysis is also prepared under the adequate control route. This would be helpful in particular to the Committees when proposing to the Commission the duration of the review period. Furthermore, if the ECHA Committees do not support the applicant's assessment according to which the risks are adequately controlled, the application can still be evaluated on the provided socio-economic analysis.

How should the "economic feasibility" criteria be interpreted?

Based on Articles 60(4) and 64(4)(b) of the REACH Regulation the Committee for Socio-economic Analysis (SEAC) needs to state in its opinion, if the alternatives to the substance that is applied for are suitable. Economic feasibility is one aspect of this. It is recognised that the evaluation of economic feasibility is intrinsically linked with the evaluation of the other aspect of suitability of the alternatives, i.e. technical feasibility. Usually the more difficult (or easy) it is to substitute a substance the more expensive (or cheap) it is to do this. The note below describes how SEAC intends to evaluate economic feasibility as part of applications for authorisation recognising the link with technical feasibility.

What is the level of details needed for the analysis of alternatives?

The applicant should undertake an Analysis of Alternatives as if they will be unable to use the substance in question beyond the sunset date, that is, as if their application for authorisation is not granted. Thus, the level of detail should be whatever the applicant would normally use when choosing alternative substances or technologies in his business. However, as stated in the guidance on applications for authorisation: "It is strongly recommended that the applicant demonstrates that a comprehensive and adequate assessment of alternatives has been done. This is because the Agency in its opinions and the Commission in its assessment of whether suitable alternatives are available will take "all relevant aspects" into account {Art. 60(5)}, including information submitted by interested third parties." However, regarding the assessment of the risks arising from the use of the alternative and the comparison of these risks with the ones arising from the use of the Annex XIV substance "the applicant is not required to generate new hazard data or provide a chemical safety assessment for each of the alternatives. Nor is it required that the risks associated with alternative substances or technologies are assessed in the same detail as the risks associated with the Annex XIV substance."

In conclusion, the level of effort that needs to be put into the analysis of alternatives will be a matter of judgment for the applicant and should reach a point where the applicant is comfortable in defending its analysis in front of the ECHA Committees.
 

Should I consider in my socio-economic analysis the aspects outside the EU?

Yes, if they are relevant. However, the focus of the socio-economic analysis should be the EU but information on effects outside the EU may be relevant as well. See chapter 2.4.3 in the "Guidance on the preparation of socio-economic analysis as part of an application for authorisation"[PDF] for more information. 

g) Technical instructions for specific Annex XIV entries

The entry for Hexabromocyclododecane (HBCDD) indicates 2 EC entries and 5 CAS entries. How should the substance identification sections (1.1 and 1.2) in an IUCLID application for authorisation dossier be filled in?

The Annex XIV entry for HBCDD is a relatively broad entry, which might be considered to describe UVCB substances (with undefined Br positions), as well as multi-constituent substances (containing more than one defined diastereoisomers at concentrations between ≥10% and <80%), and mono-constituent substances (one diastereoisomer ≥80%).

If the application concerns one particular HBCDD substance (either UVCB, or multi- or mono-constituent), then sections 1.1 and 1.2 should describe this specific substance, following the general instructions provided in the Manual: How to prepare an application for authorisation (link to: https://echa.europa.eu/manuals).

Should the application concern more than one substances covered by the HBCDD entry (for instance due to different manufacture processes by one manufacturer, or in case of a joint application with applicants manufacturing/importing significantly different HBCDD substances), the application can still be considered as an application for "one Annex XIV substance". Therefore ECHA will charge a fee for "one substance", and the IUCLID dossier shall accordingly contain one substance dataset.

In this latter case, for technical reasons in section 1.1 of the IUCLID application dossier the following information should be filled in: IUPAC name: Hexabromocyclododecane; Type of substance – Composition: other: multiple substances under Annex XIV entry. The actual compositions of the substances applying for can be listed individually as different compositions in section 1.2 by using the repeatable block-function. In the "Brief description" field of each listed composition, please indicate also a remark, e.g. "substance manufactured from manufacturing site A" or "substance manufactured/imported by applicant B".

It is reminded that the REACH Annex XIV substance entry number (for HBCDD this number is "3") shall always be given in section 1.3 of the IUCLID dossier.

General instructions on how to prepare an IUCLID application for authorisation dossier are provided in the Manual: How to prepare an application for authorisation (link to: https://echa.europa.eu/manuals)

Can an application for authorisation for chromium trioxide cover the use of the chromic acids and their oligomers generated from adding chromium trioxide to water?

Yes. The reasoning and some example are provided below.

When brought in contact with water, chromium trioxide (EC number 215-607-8) forms two acids and several oligomers: Chromic acid (EC number 231-801-5), Dichromic acid (EC number 236-881-5), Oligomers of chromic acid and dichromic acid (further referred as "Chromic acids and their oligomers"). These chemical species are all identified as substances of very high concern (SVHC) and included in Annex XIV1 as two separate entries. Latest Application Date (21 March 2016) and Sunset Date (21 September 2017) are identical for both entries.

Chromic acids and their oligomers generated in water from chromium trioxide are commonly referred to as an aqueous solution of chromium trioxide. With regard to the authorisation requirements, it may be justifiable in some situations to consider for practical reasons chromic acids and their oligomers as an aqueous solution of chromium trioxide.

The generation of chromic acids and their oligomers by adding chromium trioxide to water is a use of a substance under REACH. This may be a discreet use of chromium oxide by a formulator or part of an integrated process in the use of chromium oxide. Considering this in the context of applications for authorisation, this operation should be considered as a "use applied for" and be addressed in the chemical safety report (CSR), the analysis of alternatives and, if appropriate, in the socio-economic analysis. Hence, applications for authorisation that are meant to cover further uses down the supply chain after the initial step in which chromium trioxide is brought in contact with water, have to refer to the chromic acids and their oligomers.

This answer is strictly limited to chromium trioxide and chromic acids and their oligomers generated from chromium trioxide in water. The system in aqueous solution is a complex equilibrium between multiple chemical species which depends on several physico-chemical parameters and the different chemical species cannot be isolated from the aqueous solution. The answer should thus not be applied by analogy to any other substance.

The table below describes possible scenarios in the case of an application for authorisation is made by the manufacturer/importer/user of chromium trioxide and/or chromic acids and their oligomers. Technical instructions are provided in the last column of the table.

As a general rule, sections 1.1, 1.2 and 1.3 of IUCLID should always refer to the substance applied for (i.e. the substance indicated in the third column - "Application for authorisation" of Table 1). In addition, if there is more than one substance which is imported/used (scenario #2 below) or if the substance actually imported/used is different from the substance applied for (scenario #3b below) this information should be described in section 1.2.

For each use, the assessment performed in the assessment reports (CSR, analysis of alternatives (AoA) and socio-economic analysis (SEA)) should relate to the substance relevant for that use. The substance at the use level (e.g. chromic acids and their oligomers - used in electroplating) might indeed differ from the substance applied for (e.g. chromium trioxide) in terms of hazard, physical form / potential for exposure to Cr(VI), alternatives, etc.

Table 1 - Possible scenarios in the case of an application made by the manufacturer/importer of chromium trioxide and/or chromic acids and their oligomers2

 

Scenario # Actor / Scenario Application for authorisation Explanation / Technical instructions
1 Manufacturer / importer/User of chromium trioxide who generates chromic acids and their oligomers in water applies for an authorisation for this use and the further uses of chromic acids and their oligomers (by itself and/or its downstream users) One application for authorisation for chromium trioxide covering the further uses of the chromic acids and their oligomers Substance ID in IUCLID
  • Section 1.1:indicate chromium trioxide as reference substance
  • Section 1.2: describe the actual composition of chromium trioxide
  • Section 1.3: indicate the A.XIV entry 16 (entry number for chromium trioxide)
Assessment reports in IUCLID (CSR, AoA, SEA):
  • Assessment to be based on the relevant substance per use (chromium trioxide or chromic acids and their oligomers). The two substances may differ e.g. in terms of hazard, form / potential for exposure to Cr(VI), alternatives etc.
2

Importer/User of both
- chromium trioxide
and
- chromic acids and their oligomers generated in water from chromium trioxide

applies for an authorisation for the generation in water  of chromic acids and their oligomers and their further uses (by itself  and/or its downstream users)
 

One application for authorisation for chromium trioxide covering the further uses of the chromic acids and their oligomers

The application should be made for chromium trioxide making clear that chromic acids and their oligomers are also imported/used.

Substance ID in IUCLID:

  • Section 1.1: indicate chromium trioxide as reference substance
  • Section 1.2: describe as first composition the actual composition of chromium trioxide and as second composition the actual composition of chromic acids and their oligomers. In addition, indicate in the "brief description" field that both chromium trioxide and chromic acids and their oligomers are imported/used.
  • Section 1.3: indicate the A.XIV entry 16 (entry number for chromium trioxide)

Assessment reports in IUCLID (CSR, AoA, SEA):

  • Assessment to be based on the relevant substance per use (chromium trioxide or chromic acids and their oligomers). The two substances may differ e.g. in terms of hazard, form / potential for exposure to Cr(VI), alternatives etc.
3 Importer/User of chromic acids and their oligomers generated in water from chromium trioxide applies for an authorisation for the further uses of chromic acids and their oligomers (by itself and/or its downstream users) One application for authorisation either for
  1. chromic acids and their oligomers generated from chromium trioxide covering the further uses
  2. or for
  3. chromium trioxide covering the further uses of chromic acids and their oligomers

In case the importer/user decides to apply for an authorisation for chromic acids and their oligomers in an application for chromium trioxide (case b), it has to become clear from the application that what is actually imported/used are chromic acids and their oligomers:

Substance ID in IUCLID:

  • Section 1.1: indicate as reference substance the substance applied for: either chromic acids and their oligomers (case a) or chromium trioxide (case b)
  • Section 1.2:
    • in case a): describe the actual composition of chromic acids and their oligomers
    • in case b): for technical reasons describe as first composition the composition of chromium trioxide (100% purity) and as second composition the actual composition of chromic acids and their oligomers. In addition, indicate in the "brief description" field that what is actually imported/used are chromic acids and their oligomers.
  • Section 1.3 indicate the A.XIV entry of the substance applied for: 17 if applying for the chromic acids and their oligomers (case a) or 16 if applying for chromium trioxide (case b)

Assessment reports in IUCLID (CSR, AoA, SEA):

  • Assessment to be based on chromic acids in terms of e.g. in terms of hazard, form / potential for exposure to Cr(VI), alternatives etc.

 

4 Manufacturer/Importer/User of chromic acids and their oligomers generated by alternative methods other than from adding chromium trioxide to water3
or
Importer/User who is unaware of the manufacturing methods of the chromic acids and their oligomers applies for an authorisation for the further uses of chromic acids and their oligomers (by itself and/or its downstream users)
One application for authorisation for chromic acids and their oligomers covering the further uses

The approaches described above cannot be applied as the starting material for manufacturing chromic acids and their oligomers is not chromium trioxide or is not known.

Substance ID in IUCLID:

  • Sections 1.1: indicate as reference substance: chromic acids and their oligomers
  • Section 1.2: describe the actual composition of chromic acids and their oligomers
  • Section 1.3: indicate the A.XIV entry 17 (entry number for chromic acids and their oligomers)

Assessment reports in IUCLID (CSR, AoA, SEA):

  • Assessment to be based on chromic acids and their oligomers, in terms of e.g. hazard, form / potential for exposure to Cr(VI), alternatives etc.

 

Please see also Q&A=804 (Do chromic acids and their oligomers, generated in water from chromium trioxide, require their own registration under REACH?)

1  Entry#17: 'Acids generated from chromium trioxide and their oligomers. Group containing: chromic acid, dichromic acid, and oligomers of chromic acid and dichromic acid' And Entry#16: 'chromium trioxide'

2  Chromic acids and their oligomers generated from chromium trioxide could be described in IUCLID sections 1.1 and 1.2 e.g. as a UVCB substance with IUPAC name "Acids generated from chromium trioxide and their oligomers" and Brief description "complex composition typically including oligomers of chromic and dichromic acids in equilibrium with each other". As constituents there could be listed i) chromic acid, ii) dichromic acid, and iii) oligomers of chromic and dichromic acids.

3  Further clarification may be needed as to whether alternative methods would lead to similar equilibrium as for aqueous solutions

h) Changes of legal entity

What is a change of legal entity that needs to be notified for applications for authorisation or granted authorisations?

A change of legal entity is a change of the legal person who is the applicant of an authorisation or an authorisation holder. This change can take place, for instance, as the result of a merger, a split or an asset sale (sale of a production site or business). See Q&A 1242. Also purely administrative changes such as a change of corporate name or address and a change of Only Representative (OR) of a non-EU company need to be notified. See Q&A 1253.

 

Can an application for authorisation or a granted authorisation be transferred?

Yes. An application for authorisation or a granted authorisation can be transferred as long as the transfer is the result of the change of legal entity referred to in Q&A 1239 and the person to whom it is transferred qualifies as manufacturer, importer or downstream user with regard to the substance(s) and the use(s) covered by the application for authorisation or the decision. For details, see Q&As 1239 and 1242. On Only Representatives, see Q&A 1250.

Please note that a change of legal entity cannot extend the scope of the original application for authorisation or of the authorisation, e.g. to cover different uses.

How can I notify a change of legal personality regarding an application or an authorisation?


Please follow the next steps:

  • If relevant, create a new REACH-IT account for the successor legal entity. This is relevant when the new legal entity did not have a REACH-IT account before.
  • Log into the REACH-IT account of the original legal entity and from the Menu select Manage company | Legal entity change | Initiate a legal entity change. Then follow the online instructions. For the submission, include two attachments:
  1. Evidence of change, for instance the merger agreement or the agreement of the sale of assets.
  2. Filled announcement using the format indicated below. This describes the change of legal entity and the concerned application(s) or authorisation(s), as well as provides an analysis of the key impacts. It needs to be signed by both the original and the successor legal entity.

See also Q&A 1247.
Remember, that if the original entity has other REACH assets (e.g. registrations), the change of legal entity may need to be notified, too, via the same functionality in REACH-IT. See ECHA’s Practical Guide and technical instructions provided in the REACH-IT tool.

 

Do I have to pay a fee when notifying my change of legal entity?

Currently no fee needs to be paid for this notification for the purposes of authorisation.

 

The application was submitted before the Latest Application Date. If the legal entity changes, do the transitional arrangements set out in Article 56(1)(d) of REACH continue to apply to the legal successor?
Yes, provided that the change does not imply an extension of the scope of the original application (see Q&A 1241).
What will ECHA and the European Commission do and by when, following a notification of a change of legal entity regarding i) a pending application or ii) authorisation decision?

If the change concerns a pending application for authorisation, ECHA will communicate whether the notified change corresponds to the requirements described in Q&A 1241 and is properly documented. Furthermore, it will give its view on whether the change is minor (i.e. purely administrative changes and changes that would not have material implications on the content of the application or the terms of the RAC and SEAC opinions) or major (i.e. all other cases). ECHA endeavours to process notifications in two weeks. If the change is confirmed, ECHA will provide to the original legal entity a token. The original legal entity will need to communicate the token to the successor legal entity, who will need to accept the legal entity change in REACH-IT. The change is considered valid as of the date of the notification.

In this case ECHA will amend its database concerning the change of the legal entity. If the change is major, the RAC and the SEAC might need additional time to assess the implications of the change during the opinion-making process. If ECHA has already adopted an opinion, it will send its assessment to the European Commission so that it can take this into account when deciding on the authorisation.

In cases concerning granted authorisations, ECHA will send its assessment on the nature of the change to the European Commission, including its assessment on whether a review of the authorisation should be triggered on the basis of Article 61(2) of REACH.

The timelines for the assessment about any implications for the RAC and SEAC opinions or for the authorisation decision (potential trigger of a review of the authorisation) depend on the stage in the process at which the notification was made.

ECHA or the Commission may request for clarifications or additional information concerning your notification.

 

When do I need to inform ECHA about the change of legal entity?

As soon as it has taken place, i.e. when you have documentary evidence that you can send to ECHA. To reduce uncertainty you can also consult ECHA on the specific case in advance, provided you have sufficient information about the foreseen change. For any questions, please contact ECHA at legal-entity-changes-authorisation@echa.europa.eu

I am preparing an application for authorisation while knowing that a change of legal entity will take place in the near future. How should I address this in the application?
As you foresee a change of legal entity, to the extent feasible we recommend to also describe this in the application and analyse the potential consequences of this change in your assessment. This would facilitate the assessment of the application by ECHA / the Commission once such change has occurred. You are advised to use the same format as in Q&A 1242 for reporting your analysis of the key impacts on the information in the application.
Does a change of an Only Representative (OR) concerning an application for authorisation or a granted authorisation need to be notified to ECHA and how?

Yes.

Please proceed as follows:

  • Create a new REACH-IT account for the new Only Representative. 
  • Log into the REACH-IT account of the original Only Representative and from the Menu select Manage company | Legal entity change | Initiate a legal entity change. Then follow the online instructions.

ECHA will verify the evidence of the change and inform you as soon as it has updated its databases. In case of a granted authorisation, ECHA will also forward your notification to the European Commission.

Does a change of corporate name of an applicant or an authorisation holder need to be notified to ECHA and how?

Yes.

Please submit the notification as follows:

  • Log into REACH-IT and use the “change name” functionality to update the name. Please provide in REACH-IT an extract from commercial register as evidence of the change.

ECHA will verify the evidence of the change and inform you as soon as it has updated its databases. In case of a granted authorisation, ECHA will also forward your notification to the European Commission.

i) Review reports

What is difference between a Review Report and the Application for Authorisation?

The Review Report updates the Application for Authorisation (AfA), and it must be sent to ECHA. The fee is the same as the one for an AfA. The Review Report will follow the same process as for an AfA. The greater the relevant technical and other progress during the review period, the greater the need to update the information. The information elements are the same. In other words, a Review Report should include an updated version of the assessment reports submitted in the original application (Chemical Safety Report, Analysis of Alternatives and – when relevant – an updated Socio-economic Analysis and an updated Substitution Plan). The use description may also need to be updated e.g. to reflect a more narrow scope. 

See Section 6 of the Practical Guide “How to apply for an authorisation” at https://echa.europa.eu/documents/10162/13637/apply_for_authorisation_en.pdf/bd1c2842-4c90-7a1a-3e48-f5eaf3954676
All the Q&As related to Applications for Authorisation are also valid for Review Reports mutatis mutandis.

I have submitted my Review Report on time i.e. at least 18 months before the end of the review period. The Commission has not issued its decision before the end of the review period. Can I continue to use the substance according to the authorisation decision until the Commission issues its decision?
Yes, until a decision on the review (maintaining, amending or withdrawing the authorisation) is adopted - see also Q&A 0571; 0572; 0573 which relate to the submission windows and the (latest) submission dates. The Q&As are also applicable to Review Reports.
I have submitted my Review Report too late i.e. less than 18 months before the end of the review period. The Commission has not issued its decision before the end of the review period. Can I continue to use the substance according to the authorisation until the Commission issues its decision?
No, the substance cannot be used after the end of the review period. You will have to wait the Commission’s decision before you can continue using the substance.
Can I submit a Review Report for a use that has not been authorised?
No. To submit a Review Report, the use has to be the one for which you have an authorisation. But you can submit a new Application for Authorisation.
Can I narrow down the scope of the authorised use in a review report to be more specific?
Yes. As long as your use is within the scope of the authorised use, but more narrowly defined, you can prepare a Review Report for the review of the authorisation. No need to make a new application in this situation. 
In the Review Report, can I split my use which was originally authorised into two or more specific, more narrowly defined different uses?
Yes you can, as long as each of the new redefined uses are within the scope of the previously authorised use. Please explain this clearly in the explanatory note to be submitted with the review report. In this case an updated version of the Chemical Safety Report, Analysis of Alternatives and – when relevant – a Socio-economic Analysis and a Substitution Plan must be submitted for each use. Splitting the use will have an effect on the fee (i.e., an additional charge will be imposed for the second use). At the same time in some cases this may make your Review Report clearer and more focussed, which helps ECHA’s scientific committees’ evaluation and the Commission’s decision making.
Will ECHA’s Scientific Committees use the information gathered from the downstream user notifications (based on REACH Article 66) during the evaluation?
Yes.
Will ECHA’s Scientific Committees use information from enforcement authorities?
Yes. Authorisation holders should use this information too, when preparing the Review Report.
Will I be able to submit another Review Report after this one as a result of a new Commission’s decision?
Yes.
I was unable to demonstrate adequate control of risks for a threshold substance in the original application that I submitted originally. Will I need to do so in the Review Report?
No, you do not have to. However, it would be advisable to do so. Moreover, you shall ensure and demonstrate in the review report that the exposure is reduced to as low level as is technically and practically possible. 
How will I submit the Review Report?
You can submit it to ECHA in the same manner as the original application, using the formats available for that purpose on the ECHA’s website. However, you will naturally need to indicate that it is a Review Report and make a link to the original application. You will also need to write an explanatory note which briefly explains what is different in the review report compared to the original application. For details see the Guide “How to apply for authorisation”: https://echa.europa.eu/documents/10162/13637/apply_for_authorisation_en.pdf/bd1c2842-4c90-7a1a-3e48-f5eaf3954676
CoRAP e valutazione delle sostanze

When a substance is included in the CoRAP, are there any mechanisms by which a registrant can challenge the inclusion or provide input into the evaluation process?

Registrants cannot challenge the inclusion of a substance into the CoRAP (Community Rolling Action Plan).

However, registrant(s) may provide input into the evaluation process. Registrant(s) of a substance in the CoRAP, particularly those substances on the current year of the CoRAP are encouraged to contact the evaluating Member State Competent Authority (eMSCA) early on in the evaluation process. The contact details for the eMSCA are published in the CoRAP. If the dialogue has not already started, the eMSCA will usually contact the lead registrant when the evaluation starts and offer the opportunity to meet to discuss technical issues related to substance evaluation. The registrants should consider nominating a representative for interacting with the eMSCA. The interaction between registrant(s) and the eMSCA at this phase of the evaluation is informal.

When the outcome of a substance evaluation is that an information request to clarify the suspected concern is deemed necessary (i.e. the evaluating MSCA prepares a draft decision on substance evaluation), the registrant(s) will get the opportunity to formally comment within 30 calendar days on any draft decision as part of the decision making process (Articles 50-52 of the REACH Regulation). The evaluating MSCA shall take the comments of the registrant(s) into account and decide whether the draft decision needs to be amended on the basis of the comments/additional information provided by the registrant(s) (Article 50(1) of REACH).

ECHA communicates to the registrant(s) the draft decision as notified to the other MSCAs and ECHA and the received proposals for amendment. At this stage, the registrant(s) will have the opportunity to comment on the proposals for amendment (Article 51(5) of REACH). Registrants are reminded of their obligation to always keep their registration dossier up to date, cf article 22(1).

What is substance evaluation?

Substance Evaluation is an integral part of the REACH implementation. It aims to clarify whether a substance, which has been identified as being of potential concern, poses an actual risk to human health and/or the environment. To clarify the risks, the registrants may be asked for more information on the substance. Substance evaluation shall be carried out by the Member States, whilst ECHA coordinates the procedure. The substances to be evaluated annually are listed in the CoRAP (Community Rolling Action Plan).

Which Member States will evaluate the listed substances?

Member States may volunteer to evaluate a substance. Two Member States may also decide to make a joint evaluation. However, in all cases only one Member State will be designated as the responsible Member State for the evaluation. Final allocation of the substances to the Member States is decided with the adoption of the CoRAP by ECHA, based on the opinion of the Member State Committee (MSC) on the draft CoRAP. Thus, the CoRAP will include for each substance on the list the Member State responsible for the evaluation. The contact information of the responsible competent authority will also be reported for the substances to be evaluated in the first year, to inform the stakeholders about the body handling each substance.

In case of joint evaluations by two Member States, the co-evaluating Member State is also indicated in the CoRAP.

What happens after the CoRAP is adopted?

From the publication of the CoRAP, the respective Member States have one year to evaluate substances listed for the first year (n) and, where regarded as necessary, to prepare a draft decision for requesting further information to clarify the suspected risks. The evaluation of the substances listed for the second and third year starts only after the publication of the CoRAP update in year n+1 and year n+2 respectively.

What is the difference between dossier evaluation and substance evaluation under REACH?

Dossier evaluation comprises the examination of testing proposals and compliance check of registration dossiers. Testing proposals are triggered by the REACH information requirements and all testing proposals submitted by the registrants must be examined by ECHA. The aim of this examination is to decide on the most appropriate testing in order to fulfil the REACH information requirements. ECHA can perform a compliance check on any registration dossier to verify whether the REACH information requirements are met. Dossiers can be chosen for compliance check based on random selection or prioritised based on a specific concern.

The substance evaluation process is triggered as a result of risk-based concerns and aims to clarify whether a substance poses a risk for human health or the environment. Substance evaluation is targeted at substances (including aggregated tonnages, all uses, etc.). Under substance evaluation any information (beyond the REACH requirements) can be requested provided that it is considered necessary for the purposes of risk assessment of the substance.

Substance evaluation is carried out by the Member States, while ECHA is responsible for dossier evaluation.

The decision making process is essentially the same for both processes.

What is the added value of substance evaluation?

Substance Evaluation may identify risks that could otherwise be missed. This process can further create additional value in respect of:

  • Concerns that go beyond the control of the individual registrant, like regional risks or the potential additional risk caused by aggregated exposures of a (sub)population or releases into the environment.
  • The assessment of groups of similar substances to predict cumulative effects and potentially increased risk levels from exposures to the different substances in the group. 
  • If considered scientifically necessary and proportionate, the request for additional information can go beyond the standard information requirements in REACH.
Why is a substance on the CoRAP list? Which criteria have been used?

The REACH Regulation Article 44(1) provides the general criteria for substances to be selected for substance evaluation. The legal text defines that prioritisation shall be on a risk-based approach. According to Article 44(1): "(...) the criteria shall consider:

hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;

exposure information; tonnage, including aggregated tonnage from the registrations submitted by several registrants".

The criteria have been refined by ECHA in cooperation with the Member States and are published on ECHA's website: Selection criteria to prioritise substances for Substance Evaluation (2011 CoRAP selection criteria) http://echa.europa.eu/documents/10162/13628/background_doc_criteria_ed_32_2011_en.pdf.

These criteria are applied in the initial step of the identification of substances with potential concerns. A further screening and selection process takes into consideration whether the substances are already subject to regulatory measures and the effectiveness of the substance evaluation to clarify the concern by requesting further information on the substance. Thus, meeting the risk-based criteria alone does not automatically mean an inclusion of the substance in the CoRAP.

According to Article 45(5) of the REACH Regulation, a Member State may notify ECHA of a substance, whenever it is in possession of information suggesting that the substance is a priority for evaluation. Thus, the CoRAP may also contain substances that have been included based on notifications from Member States.

Both hazard and exposure information (or a lack of it) is taken into consideration upon prioritising the substances. In the first CoRAP with many substances, the initial concerns are generally related to potential PBT-properties, suspected endocrine disruption, or carcinogenic, mutagenic and reprotoxic properties in combination with wide dispersive or consumer use(s) and/or high tonnages. In general, the uses of these substances cover various areas and do not focus on any particular industrial, professional or consumer uses.

The final published CoRAP also contains a general indication of the reasons why the substance was prioritised and selected for substance evaluation (grounds for concern). Before inclusion in the CoRAP, the substances have not been evaluated and thus the indicated grounds for concern are just an indication of the possible areas of risk, based on the selection criteria. The initial grounds for concern should not be taken as a statement on a known risk or as a statement on what the evaluation will cover. During the evaluation, other areas of concern may be identified and investigated further. Only after the substance evaluation is completed, risks can be defined and communicated. The Member States have agreed that from the first update of the CoRAP in 2013, more detailed justification documents regarding selection of each substance will be prepared and published.

What does a known or suspected property mean in the grounds for concern in the CoRAP?
For example, the difference between known and suspected CMR-property is the following: "Known" means that the substance has either a harmonised classification and labelling or a self-classification chosen by the registrant(s) for one or more of the CMR-properties. "Suspected" means that e.g. non-conclusive information on intrinsic properties or results of structural prediction models indicate that the substance could have CMR-properties.
 
(CMR = carcinogenic, mutagenic, toxic to reproduction)
When was the first CoRAP adopted?
ECHA submitted a draft CoRAP to the Member State Competent Authorities and the ECHA Member State Committee in October 2011. The draft CoRAP was also published on the ECHA website to inform the stakeholders. The Committee gave its opinion on the draft CoRAP in February 2012. On the basis of the Committee's opinion, ECHA adopted the first CoRAP on 29 February 2012.
Is the CoRAP a new "black list" of chemicals?
The CoRAP list is neither a black list nor a sunset list, i.e. it will not cause a substance to be taken off the market. Instead, substance evaluation is a mechanism to evaluate and get more information on the substances listed therein, when there are concerns that the substances may pose a risk to human health or the environment. The evaluation can result in the conclusion that the concern is resolved and thus no further action is needed. If the initial concern is confirmed in substance evaluation, the Member State may consider further risk management options such as harmonised classification and labelling, restriction or authorisation to control that risk for a respective substance. However, that would be subject to a separate process.
What is the impact of substance evaluation on my business?

The listing of a substance on the CoRAP does not in itself have any legal impact on the registrant and thus does not require any further action by the registrants. When the CoRAP is adopted/updated, the registrants of substances listed for the first year of the CoRAP may expect to receive a draft decision requesting further information after the evaluation period of 12 months. At that point of time, the registrants will be given an opportunity to comment before any final decision to request further information is taken. The final decision will contain a deadline by which the additional information must be submitted.

On the other hand, if the evaluating Member State comes to the conclusion that no further information is necessary to clarify the risk, the substance evaluation process is concluded without a decision to request further information.

Inclusion of a substance in the CoRAP does not automatically mean that the substance poses a risk to human health or the environment, but rather that there is a concern that it may pose a risk, which needs to be clarified (confirmed or dismissed). It also does not automatically trigger, for example, the restriction or authorisation process. However, the Member State responsible for the evaluation of a substance may consider these options once the evaluation is finished, if the risk is confirmed.

Once adopted, is CoRAP fixed?
The CoRAP list will cover a period of three years. The first CoRAP thus includes substances planned for evaluation in the years 2012, 2013 and 2014. The plan should be annually updated. ECHA will make a proposal for the annual update at the latest by 28 February each year. However, currently ECHA plans that the updated CoRAP could already be adopted by the end of February and thus the draft for the CoRAP would be prepared and communicated already in October/November of the previous year. Thus, the first update is expected in February 2013. The rolling nature of the plan means that the list of prioritised substances included for evaluation during the second and third year may change when the plan is updated (e.g. a substance may be dropped or new ones introduced) and that each year a new subsequent year is added.
Is there any interaction between the evaluating Member State and the registrants/stakeholders?

The REACH Regulation does not foresee any formal interaction during the 12 month evaluation process i.e. before the possible draft decision is prepared. Once the draft decision is issued, the registrants will be contacted via REACH-IT. During the decision making procedure registrants will be consulted on any prepared draft decision and proposals made to amend this draft decision. The registrants may submit comments that will be taken into account in the decision making of the evaluating Member State and by the Member State Committee, if the draft decision is referred to the Committee.

The possibility for registrants/stakeholders to interact with the evaluating Member State during the evaluation phase may differ between Member States and substances that are evaluated. However, interaction between the registrants / stakeholders and the evaluating Member State is appreciated in general under substance evaluation. Thus, all relevant information available to the registrants of the substances should be included in the registration dossiers by the start of evaluation (i.e. March each year).

What is the outcome of substance evaluation?

If the evaluating Member State considers that further information is necessary to clarify a potential risk caused by the substance, it may draft a decision specifying the additional data requests. The initially identified concern in the CoRAP does not limit the evaluation made by the Member States and thus the potential request can address any property or exposure scenario of the substance. The registrants of that substance will have an opportunity to provide comments on the draft decision. Such a draft decision will be reviewed and agreed by the other Member States and ECHA, and in the case of proposals for amendment also by the Member State Committee. After this procedure, ECHA will take the final decision in line with the agreement in the Member State Committee. If no unanimous agreement is reached by the Member State Committee, the decision will be taken by the European Commission. The decision will contain a deadline by which the registrants must submit the requested information. It may also be that no request for information is needed because the risks can be clarified with the information already available.  In such cases, the substance evaluation is considered to be completed.

Once the registrants submit the requested information, the responsible Member State has another 12 months to assess this information and decide whether a further request for information is necessary or whether the evaluation can be concluded. In this latter case, the responsible Member State should consider whether and how to use the information obtained for the purposes of Community level risk management measures. The Member States may conclude:

  • EU-wide risk management measures are necessary (e.g. EU wide restriction, EU-wide authorisation, EU-harmonised classification and labelling, occupational exposure limits, measures for the protection of the environment under the Water Framework Directive) or
  • Actions at national level should be taken.

The conclusion can also be that the risks are sufficiently under control with the measures already in place. ECHA informs the European Commission, the registrant and the other Member States about the conclusions.

The decisions on data requests and evaluation reports will be made publicly available once finalised. It should be noted that as the production of the information requested may, in some cases, take several years (e.g. in the case of long term studies and annual environmental monitoring) finishing a final evaluation report may also take several years from the adoption of the CoRAP.

After adoption of the CoRAP, when can a possible first decision requiring further information on a substance be expected? If further information is requested, when would this become available?

From the publication of the CoRAP (March each year), the Member States have 12 months to prepare a draft decision for a substance included for evaluation during the first year, i.e. by end of February of the following year. After that, the decision making process may take approximately four to eight months depending on whether the Member State Committee is involved or not. Thus under favourable conditions, first decisions are likely to be taken between the middle and end of the following year after CoRAP inclusion. The registrants will have the opportunity to comment on the draft decision before the final decision is taken.

The decision will define the deadline by which the registrant(s) must provide the necessary information. Depending on the type of information, the deadline may be between some months and several years.

What is the follow up of substance evaluation?

"Follow up" under substance evaluation means: once the requested information is available and evaluated by the Member State, it will consider whether and how to use the information obtained for the purposes of Community level risk management measures.  The follow up can either be no action or recommendation to take further actions, such as to propose EU wide risk management measures.

A follow up conclusion under substance evaluation is not directly initiating further risk management measures. Any proposed Community-wide actions will be subject to a separate decision making process and Member States need to file a notification for this purpose. For authorisation, restriction and/or harmonised classification under the REACH and the CLP Regulations, stakeholders are consulted at all relevant stages of the process and decisions are taken on the basis of the opinions adopted by the ECHA Committees.

Are substances in the (draft) CoRAP going to be included in the authorisation/restriction processes?
There is no direct link between the CoRAP and the authorisation/restriction processes. While inclusion in the CoRAP means that a substance is going to be evaluated by a Member State to clarify whether there is a potential risk by asking further information, the restriction or authorisation processes aim to control known risks, which cannot be managed by other risk reduction measures. Thus, a follow-up to substance evaluation may be that a Member State wishes to start an authorisation or restriction process.
Where can I get more information on the CoRAP substances?

Information on the substances is available on the ECHA website. This website contains non-confidential information on the properties and uses of the substances that have been retrieved from the registrations for each substance.

Decisions on requests of further information and substance evaluation reports prepared by the Member States will also be published on the ECHA website, when they are available.
Dissemination portal:
http://echa.europa.eu/information-on-chemicals/registered-substances

CoRAP-substances:

https://echa.europa.eu/information-on-chemicals/evaluation/community-rolling-action-plan/corap-table

Completeness check

General questions

Is there any obligation according to Article 21 of REACH to interrupt the manufacture or import of the substance during the technical completeness check (TCC)?

Manufacture or import does not need to be interrupted during the completeness check of a dossier when the dossier is submitted to update an existing registration, which already has a registration number assigned, for the following reasons: (i) when the reason for the update is to respond to an ECHA communication or decision requesting additional information; or (ii) the registrant has new and relevant information about the substance, and its uses and properties. However, if the update is made to increase the scope of the registration (e.g. increase of tonnage band, or change from an Article 17/18 registration to an Article 10 registration), the new scope cannot be applied in the manufacture/import until the dossier has successfully passed the completeness check.

For new dossiers submitted to obtain a registration number, the following scenarios exist:

  • In the case of a non phase-in substance for which the manufacture or import is to be started, the waiting period must be respected as the assignment of the registration number, and the right to manufacture or import the substance, rely on the submission of a complete registration dossier to ECHA and the granting by ECHA of a registration number.
  • In the case of a phase-in substance which was pre-registered, and for which the relevant registration deadline has not yet passed, there is no requirement to interrupt manufacture of import during the completeness check. Such substances may be manufactured and imported until their relevant registration deadline without a registration number. If a dossier for a pre-registered substance is submitted immediately before its relevant registration deadline, but fails the completeness check, ECHA will set a deadline by when the dossier has to be completed. The manufacture or import of the substance may continue during this time even if the registration deadline is passed. However, if the dossier is not completed by the set completeness check deadline, ECHA will issue a decision rejecting the registration. If the relevant registration deadline has passed at this moment, the registrant cannot continue manufacture or import until they successfully submit a new registration dossier and receive a registration number for the substance.
I submitted a dossier in response to an ECHA decision under compliance check and my dossier failed the technical completeness check (TCC). The deadline given in the TCC letter is later than the deadline for the compliance check. Which deadline should I follow? What are the consequences of a second TCC failure in this case?

In the case that you submitted your dossier before the compliance check deadline had passed, you may follow the deadline given in the TCC letter. ECHA will not continue with the Evaluation process before you have submitted the requested update for the technical completeness check failure.

Should also your second submission fail the TCC, the combination of your two submissions in response to the compliance check decision will be rejected. If at this point the compliance check deadline has already passed, it means that ECHA has not received a response to the compliance check decision and may proceed with further regulatory actions. It is therefore advisable not to leave the submission of updates to regulatory requests to the last moment.

This Q&A does not apply if your submission in response to an ECHA decision under compliance check was made after the deadline indicated in that decision. In such a case you should update the incomplete dossier without                                                            delay and inform ECHA about not meeting the compliance check deadline via the contact form:  https://echa.europa.eu/contact

What are the consequences of a TCC failure close to the 2018 registration deadline? What impact will it have on the registration number of the lead and members of a joint submission?
  • To be legally on the market from 31 May 2018 onwards, any registrant (lead or member) that intends to benefit from the phase-in scheme of this particular registration deadline must have submitted a registration dossier to ECHA by this deadline. A dossier is considered to be submitted if it has been uploaded in REACH-IT and passed the business rules step, as long as it has not been rejected due to incompleteness caused by non-payment of the fee, or second failure of the technical completeness check. Please note the following in relation to a TCC failure close to the registration deadline:
  • A member registrant cannot submit a dossier before the dossier of the lead registrant of that substance has been submitted. As soon as the lead registrant submits a dossier to ECHA (uploads it in REACH-IT and passes the business rules step), member registrants of that joint submission can submit their dossiers.
  • Member registrants cannot receive their registration numbers before the lead dossier is found to be complete. This means that submitted member dossiers are ‘parked’ in the submission pipeline until a decision is taken on the completeness of the lead dossier.
  • If a registration dossier fails the completeness check, ECHA informs the registrant of the missing/incomplete information and grants a deadline by which the registrant has one attempt to complete the information. If the registrant submits all the requested information to ECHA within the deadline, the dossier will receive a registration number and the registration date will be the date of the first submission. If this dossier is the lead registrant dossier, all submitted member dossier for that joint submission will be released from being ‘parked’ and will be processed for completeness.
  • Should also the second submission result in a failure of the completeness check then the combination of the first and second submissions will be rejected and no registration number is issued for that registrant. In case the rejected submission is the lead registrant dossier, a registration number is also not issued for any member registrant of that joint submission. 

The technical completeness check (including manual checks) is in general performed on each dossier within three weeks of its submission date. However, for phase-in substances submitted in the course of the two-month period immediately before the relevant registration deadline, the completeness check may take up to three months after the deadline. Registrants who wish to have the outcome of the completeness check in advance of the 2018 registration deadline may consider these timelines.

I received a task in REACH-IT indicating that I had failed the technical completeness check. Where can I find further information on the reasons and implications of the failure?
In the task you have a link to the “Submission page” of the submission. Follow this link and go to the “Key documents” section at the bottom of the page. Here you can download the technical completeness check communication which contains all the relevant information regarding the failure, as well as the steps required by you. 
I am unfamiliar with the registration process. What does the completeness check consist of?

The completeness check is based on REACH Article 20(2). It applies to all registration dossiers submitted to ECHA; both dossiers submitted to obtain a new registration number, as well as dossiers submitted as updates of existing registrations. The completeness check consists of two parallel verifications: (i) the technical completeness check, in which ECHA verifies that all the required elements have been provided in the registration dossier; and (ii) the financial completeness check, in which ECHA verifies that the registration fee has been paid, if applicable to that submission.

If during the technical completeness check the registration dossier you submitted is found incomplete, ECHA will issue a deadline by which you have only one attempt to submit the missing or incomplete information. If you do not provide the requested information by the set deadline in the form of an update dossier, the submission will be rejected. In such a case, any registration fee you had paid in relation with this submission will not be refunded or otherwise credited.

You can find more information about the registration process on the REACH 2018 registration deadline pages: https://echa.europa.eu/support/registration/from-submission-to-decision

We also recommend you to have a look at our webinar on the technical completeness check process:
https://echa.europa.eu/-/completeness-check-preparing-a-registration-dossier-that-can-be-successfully-submitted-to-echa   

Manual checks

I noticed that in IUCLID 6, the field ‘Justification for data waiving’ contains picklist values with different justification options. However, I had prepared my data in IUCLID 5 and provided the justifications in free text. Do I have to modify all the data waiving justifications and use one of the new picklist phrases for the dossier to be considered complete?

There is no need to change the data waiving justification from free text to an available picklist phrase. A free text justification will be considered equally complete to a picklist value, whenever it is in line with column 2 of REACH Annexes VII-X, or sections 2-3 of Annex XI.

However, when preparing a dossier in IUCLID 6 from IUCLID 5 data, please review the selection in the field ‘Endpoint’ in particular for IUCLID sections where different information requirements can be addressed (e.g. 4.13, 7.8.1) to ensure that you have clearly indicated that the appropriate requirement is being waived.

Does the manual verification by ECHA staff apply to all submitted registration dossiers?

The manual verification applies to all registration dossiers submitted to ECHA. The manual checks focus on ensuring that registrants who waive or deviate from the standard information requirements provide justifications foreseen by the legislation. Therefore the extent of the verification depends on whether the dossier contains waiving of standard information or deviations from substance identification conventions, as well as on the specific requirements that apply to the registration type (i.e. lead, member, individual registration) and the registration scope (tonnage band, isolated intermediate).

For further information, please refer to the document Information on manual verification at completeness check available at: https://echa.europa.eu/manuals.

Validation assistant

How can I check my dossier for business rules and technical completeness failures before I submit it to ECHA?

As a first step, ensure to prepare your registration/PPORD dataset and dossier according to the advice given in the manual How to prepare registration and PPORD dossiers available at: http://echa.europa.eu/manuals. Annexes 1-3 of the manual also give an overview of the business rules and technical completeness check rules that apply to registration and PPORD dossiers. 

Next, use the IUCLID Validation assistant plug-in to help you detect business rules and technical completeness check failures present in your dataset and dossier. While the Validation assistant cannot replicate all the checks performed by ECHA (see below), it simulates the majority of the verifications done and helps you minimise the chance of failure during submission. It is important to keep in mind that any failure in the Validation assistant Submission checks tab that is left uncorrected before submitting your dossier in REACH-IT will lead to that your submission will not be accepted by ECHA. 

To run the Validation assistant, right click on your dataset in the Navigation panel → Validate → follow the steps in the wizard. The same validation should be performed on the dossier to make sure that no failures have been introduced during dossier creation.

You can find a video tutorials on the use of the IUCLID Validation assistant in the link below :

https://www.youtube.com/watch?v=zQEncCL8cCE&index=4&list=PLOPGDACSd6qyDkdXwPua1Fjb5bJksY75k

If the Validation assistant does not indicate any failures, this is not an automatic confirmation of that your dossier is complete. As of 21 June 2016, the technical completeness check includes additional verifications of the registration dossier by ECHA staff. These checks cannot be replicated using the Validation assistant plug-in; the related completeness issues cannot be displayed by the tool.

Information on the areas of the additional verifications can be found in the following location; the document is regularly updated with advice based on the experience gained with incoming registrations: https://echa.europa.eu/documents/10162/13652/manual_completeness_check_en.pdf.

We also recommend you to have a look at our webinar on the completeness check process: https://echa.europa.eu/-/completeness-check-preparing-a-registration-dossier-that-can-be-successfully-submitted-to-echa.

 

What should I do if the Validation assistant reports QLT warnings in the Quality checks tab?

The quality rules warn the user of common inconsistencies and shortcomings. These warnings will not prevent you from successfully submitting your dossier in REACH-IT; however leaving quality warnings uncorrected may lead to later clarification requests by ECHA.

Condivisione dei dati

A. Domande di natura generale

Come sono ripartiti i costi della raccolta dei dati?

Un accordo sulla ripartizione dei costi richiede generalmente che le parti concordino su quanto segue:

  1. l’affidabilità, la pertinenza e l’adeguatezza dei dati ("Qualità dei dati");
  2. il valore economico dei dati ("Valutazione dei dati"); e
  3. le modalità con cui il valore concordato viene condiviso tra le parti ("Assegnazione dei costi e compensazione").

I dichiaranti sono tenuti a condividere i costi delle informazioni che devono trasmettere per soddisfare i requisiti di registrazione. Le imprese non possono essere obbligate a sostenere costi di studi di cui non hanno bisogno né altresì a sostenerli prima di averne effettivamente bisogno nell’ambito della propria rispettiva fascia di tonnellaggio. Quando il (potenziale) dichiarante richiede in anticipo i dati, egli dovrà sostenere i costi non appena riceve tali dati. Potrebbero essere considerati anche altri elementi; in generale, è consigliabile giungere a un accordo sulla ripartizione dei costi prima di divulgare le informazioni disponibili.

Gli Orientamenti sulla condivisione dei dati forniscono ulteriori dettagli: http://echa.europa.eu/it/guidance-documents/guidance-on-reach.

Sono inoltre disponibili consigli pratici in materia di trattative sulla condivisione dei dati: http://echa.europa.eu/regulations/reach/registration/data-sharing/practical-advice-for-data-sharing-negotiations.

Si è soggetti ad obblighi di condivisione dei dati dopo aver presentato la propria registrazione?

Il dichiarante può essere assoggettato ad altri obblighi una volta presentata la registrazione. Ciò può avvenire quando:

  • nuovi dichiaranti potenziali aderiscono al forum per lo scambio di informazioni sulle sostanze (SIEF) in qualità di dichiaranti che hanno presentato una preregistrazione tardiva di una sostanza soggetta a un regime transitorio;
  • in seguito a una richiesta, il dichiarante potenziale di una sostanza non soggetta a un regime transitorio o un dichiarante potenziale di una sostanza soggetta a un regime transitorio che non ha effettuato la preregistrazione viene informato dall’ECHA in merito ai precedenti dichiaranti e agli altri dichiaranti potenziali (e viceversa);
  • quando, una volta completata con successo la presentazione del fascicolo di registrazione, vengono rese disponibili nuove informazioni. In tal caso, a norma dell’articolo 22 del regolamento REACH, i dichiaranti saranno tenuti ad aggiornare il fascicolo di registrazione congiunta, cosa che può comportare una condivisione preliminare dei dati e può influire sulle decisioni in materia di classificazione ed etichettatura, nonché rendere necessaria una modifica della relazione sulla sicurezza chimica (CSR);
  • in seguito alla valutazione, da parte dell’ECHA, del fascicolo presentato (controllo di conformità o valutazione di una proposta di sperimentazione) o della sostanza. Questi processi possono dare origine a una richiesta di presentazione di ulteriori informazioni che verrebbe indirizzata a tutti i dichiaranti della stessa sostanza, i quali dovrebbero accordarsi in merito alla produzione e alla condivisione dei dati e dei costi. Pertanto la condivisione dei dati si applica non solo agli studi "esistenti", ma anche a studi che si renderanno necessari per garantire che la registrazione è conforme al REACH.
Che cos’è una lettera di accesso (LoA) ai sensi del regolamento REACH?

Quando un dichiarante non possiede un rapporto di studio necessario per la propria registrazione, deve concordare con il titolare del rapporto le condizioni per il suo utilizzo ai fini della registrazione REACH. Il titolare dei dati e il dichiarante sono liberi di definire i diritti che verranno concessi.

Se il sommario esauriente di studio è stato già presentato all’ECHA, un dichiarante può, per esempio, fare riferimento a tale studio nel suo fascicolo, purché abbia il permesso di farlo. In tale contesto, il dichiarante e il titolare dei dati devono concordare le condizioni del diritto di fare riferimento. La lettera di accesso è un’espressione che si utilizza spesso per descrivere l’accordo sulla condivisione dei dati e la concessione di un diritto di fare riferimento; il dichiarante potenziale deve rispettare in ogni caso i diritti di proprietà intellettuale del titolare dei dati.

In che modo l’ECHA può assistere l’utente se il costo per la condivisione dei dati non è giustificato?

Il prezzo dei dati condivisi per ogni sostanza può variare sensibilmente a seconda dei relativi costi di studio, del numero dei dichiaranti che condividono i dati e di altri fattori.

L’ECHA ha pubblicato consigli generali sugli elementi di cui tenere conto durante le trattative sulla condivisione dei dati. http://echa.europa.eu/regulations/reach/registration/data-sharing/practical-advice-for-data-sharing-negotiations

L’ECHA non partecipa alle discussioni tra i (potenziali) dichiaranti, non è competente per regolamentare o valutare il costo per la condivisione dei dati e pertanto non può assistere un dichiarante potenziale nel corso delle sue trattative con i dichiaranti precedenti o i titolari dei dati. In ultima istanza, l’ECHA può fornire assistenza per dirimere le controversie sulla condivisione dei dati che insorgono tra dichiaranti esistenti e dichiaranti potenziali. Per ulteriori dettagli si rimanda alle pagine del sito web dell’ECHA sulla condivisione dei dati: http://echa.europa.eu/regulations/reach/registration/data-sharing/data-sharing-disputes/data-sharing-disputes-in-practice

Come è possibile ottenere da un dichiarante precedente dati presentati meno di 12 anni prima?
Situazione
La sostanza è stata registrata, ma gli studi pertinenti sono stati presentati meno di 12 anni prima della richiesta. L’ECHA comunica al dichiarante potenziale nomi e indirizzi dei dichiaranti precedenti, ma non può fornire una copia dei sommari (esaurienti) di studio. Diritti e obblighi - Ai fini della condivisione dei dati, il dichiarante potenziale dovrà contattare i dichiaranti precedenti (e/o gli altri richiedenti) indicati dall’ECHA.
La richiesta di condivisione dei dati deve essere effettuata per tutti gli studi su animali vertebrati; tuttavia, per i dati che non riguardano sperimentazioni su animali vertebrati, il dichiarante potenziale non è obbligato a richiedere i dati ai dichiaranti precedenti. Il dichiarante precedente e il dichiarante potenziale dovranno compiere ogni sforzo per addivenire a un accordo sulla condivisione dei dati richiesti e sui relativi costi. L’obbligo di fare il possibile vale per tutte le informazioni richieste, riguardanti studi su animali vertebrati o invertebrati.
Processo
Una volta effettuata la richiesta di condivisione dei dati per studi presentati meno di 12 anni prima, sia il dichiarante precedente, sia il dichiarante potenziale dovranno adoperarsi al meglio:
- per addivenire a un accordo sulla condivisione delle informazioni richiesta dal dichiarante potenziale;
- per assicurare che i costi della condivisione delle informazioni siano determinati in modo equo, trasparente e non discriminatorio.
Come è possibile prolungare il periodo di attesa del nuovo dichiarante per godere del disposto dell’articolo 27, paragrafo 8?
Situazione
Un dichiarante precedente e un dichiarante potenziale hanno concordato la condivisione di informazioni presentate meno di 12 anni prima o, in seguito a una controversia sulla condivisione dei dati, l’ECHA concede al dichiarante potenziale il permesso di fare riferimento ai dati. Diritti e obblighi - Prima della trasmissione del fascicolo di registrazione da parte del dichiarante potenziale, il dichiarante precedente può, ai sensi dell’articolo 27, paragrafo 8, chiedere all’ECHA di prolungare il periodo di attesa della registrazione di ulteriori quattro mesi. Di conseguenza il dichiarante potenziale, ricevuta conferma della corretta registrazione, dovrà attendere per altri quattro mesi prima di avere il diritto di produrre o importare la sostanza.
Processo
Il dichiarante precedente può presentare la richiesta all’ECHA al seguente indirizzo e-mail: datasharing-disputes (at) echa.europa.eu. Il dichiarante precedente dovrà fornire il numero della comunicazione (del tipo INQ-C-0000000000-00-00) ricevuta dall’ECHA in seguito alla richiesta da parte del dichiarante potenziale. Di conseguenza, tramite REACH-IT l’ECHA comunicherà al dichiarante potenziale che il dichiarante precedente ha richiesto di prorogare il periodo di attesa della registrazione di altri quattro mesi.
L’ECHA potrà verificare l’effettiva condivisione dei dati presso il dichiarante potenziale.
A fronte della ricezione del numero di registrazione, il dichiarante potenziale dovrà attendere la scadenza del periodo di attesa aggiuntivo prima di avere il diritto di produrre o importare la sostanza sul mercato europeo.
Si possono utilizzare rapporti di studio esistenti per la propria registrazione senza il consenso del proprietario?

Per utilizzare dati pubblicati ai fini dell’osservanza delle prescrizioni in materia di informazione è necessario avere il diritto di fare riferimento al rapporto di studio completo. Pertanto, se si desidera fare riferimento nel proprio fascicolo di registrazione ad un rapporto di studio completo pubblicato, occorre verificare con il proprietario dei diritti d’autore in che misura si è autorizzati a utilizzare il rapporto nel proprio fascicolo. In tal caso, si deve negoziare una licenza o un’altra forma di accordo (per es. una lettera di accesso) che consenta di fare riferimento ai dati pubblicati. Per ragioni di efficienza, un tale accordo deve garantire che tutti i membri della presentazione congiunta abbiano il diritto di fare riferimento ai dati.

Il diritto d’autore copre solo la forma d’espressione, ma non i fatti e i dati contenuti nel lavoro, perciò le informazioni di questo tipo possono essere incluse nel fascicolo senza il consenso del proprietario dei diritti d’autore, a condizione che il testo dello studio non sia copiato in quanto tale nel proprio fascicolo di registrazione. In altre parole, è possibile utilizzare i dati per redigere il proprio sommario di studio, ma occorre inserire citazioni e riferimenti opportuni allo studio originale per menzionare la fonte delle informazioni. Inoltre, anche nei casi in cui si produca un sommario di studio per conto proprio, si deve essere autorizzati a far riferimento al rapporto di studio completo ai fini della propria registrazione. Per maggiori informazioni, consultare gli Orientamenti sulla condivisione dei dati, sezione 3.3.3.8.

Do potential registrants of a substance in a low tonnage band need to apply the classification and labelling attributed to the substance during its registration at a higher tonnage band, even if they have no access to the relevant study? Do they have to contribute to the cost of this study?

All potential registrants of a substance must examine all available information and apply the relevant classification and labelling for their substance as it has been mutually agreed within their SIEF. 

If they disagree with this classification, they may decide to ‘opt-out’ from this information requirement and propose a different classification, as long as they appropriately justify their decision (Article 11(3)(c), REACH).

Nevertheless, potential registrants of a substance in a low tonnage band do not have to contribute to the cost of a study if this study is not required for a registration in their tonnage band (Article 11(2), REACH).

B. Condivisione dei dati relativi a sostanze pre-registrate

Come si può agevolare la comunicazione all’interno di un forum per lo scambio di informazioni sulle sostanze (SIEF - Substance Information Exchange Forum)?

Lo scambio di informazioni nell’ambito di un SIEF è notevolmente agevolato se un partecipante accetta di fungere da coordinatore; il coordinatore può proporre strumenti di organizzazione dello scambio di informazioni sulla sostanza. Già in fase iniziale, il SIEF può approvare il fatto che un’impresa si assuma la responsabilità di organizzare lo scambio di informazioni e di preparare la presentazione congiunta, ma ciò non è obbligatorio perché il regolamento REACH non stabilisce alcuna condizione in proposito.

Quando le informazioni da scambiare sono considerate commercialmente sensibili da uno o più dichiaranti potenziali (per es. a causa di un’impurità che può dare informazioni su un processo di produzione), tali dichiaranti potenziali possono, per esempio, proporre di concludere un accordo di riservatezza oppure di impiegare una terza parte indipendente o un fiduciario che può gestire le informazioni riservate per conto dei potenziali dichiaranti. Qualsiasi altra forma di organizzazione è ugualmente ammessa purché sia approvata da tutti i partecipanti al SIEF.

Per informazioni dettagliate su come organizzare il SIEF e agevolare la comunicazione al suo interno, consultare gli Orientamenti sulla condivisione dei dati: http://echa.europa.eu/it/guidance-documents/guidance-on-reach.

Come si gestisce un forum per lo scambio di informazioni sulle sostanze (pre-SIEF)?
REACH-IT comprende pagine web sulle sostanze che forniscono assistenza in materia di pre-SIEF e contengono due campi a testo libero per pubblicare informazioni sulla creazione dei SIEF. Il primo campo serve al facilitatore della formazione del SIEF (SFF - SIEF Formation Facilitator) per immettere i messaggi sulla creazione di un SIEF e fornire i dati di contatto e le informazioni su ulteriori strumenti di comunicazione (per es. siti web dell’industria dedicati), mentre il secondo campo è riservato a tutti i dichiaranti intenzionati a preregistrare la sostanza. Gli autori si assumono piena responsabilità di tutti i messaggi, mentre l’ECHA non verificherà né approverà o disapproverà i loro contenuti.

I potenziali dichiaranti dovrebbero impegnarsi a formare i SIEF il prima possibile, al fine di assicurare che resti abbastanza tempo per organizzare la condivisione dei dati e preparare i fascicoli di registrazione. Gli Orientamenti sulla condivisione dei dati spiegano più dettagliatamente come e quando viene formato un SIEF: http://echa.europa.eu/it/guidance-documents/guidance-on-reach
Chi può diventare un titolare dei dati in un forum per lo scambio di informazioni sulle sostanze?

Un titolare di dati è qualsiasi persona che detiene informazioni/dati pertinenti per una sostanza soggetta a un regime transitorio ed è disposta a condividerli. I titolari di dati possono essere:

  • fabbricanti, importatori e rappresentanti esclusivi di un fabbricante non appartenente al SEE di sostanze soggette a regime transitorio in quantitativi inferiori a 1 tonnellata l’anno, che non hanno effettuato la registrazione preliminare;
  • utilizzatori a valle di sostanze soggette a regime transitorio;
  • terze parti che detengono informazioni su sostanze soggette a regime transitorio;
  • qualsiasi soggetto di cui l’ECHA ha informazioni, presentate nel quadro della direttiva sui prodotti fitosanitari (91/414/CE) o della direttiva sui biocidi (98/8/CE) che soddisfa le condizioni stabilite all’articolo 15 del regolamento REACH.
I titolari di dati possono registrarsi in REACH-IT al fine di diventare partecipanti al SIEF per tale sostanza e possono fornire informazioni ad altri membri del SIEF, trasmettendo all’ECHA qualsiasi o tutte le informazioni pertinenti elencate all’articolo 28, paragrafo 1. Per ulteriori informazioni, consultare la sezione "I partecipanti al SIEF" degli Orientamenti sulla condivisione dei dati: http://echa.europa.eu/it/guidance-documents/guidance-on-reach.

Qual è la differenza tra un forum per lo scambio di informazioni sulle sostanze (SIEF) e un consorzio?

La partecipazione a un SIEF è obbligatoria per gli attori specificati all’articolo 29 del regolamento REACH, mentre l’adesione a un consorzio o a qualsiasi altra forma di cooperazione è volontaria. I consorzi costituiscono un tipo più formale di cooperazione fra dichiaranti.

Spesso si afferma che, per organizzare le attività nell’ambito di un SIEF, quali la condivisione dei dati e la loro presentazione congiunta, deve essere formato un “consorzio” (o deve essere firmato un accordo di consorzio). Tuttavia, REACH non richiede legalmente né l’uso di un “accordo di consorzio” né l’uso di altri accordi formali o scritti.

Se alcuni o tutti i partecipanti a uno o più SIEF decidono di formare un consorzio, sono liberi di stabilire i propri accordi riguardanti l’ambito di applicazione, la finalità, la durata, le condizioni per l’adesione o l’abbandono, ecc. purché tali accordi non siano in contrasto con le norme comunitarie in materia di concorrenza. Inoltre, i membri del consorzio devono cooperare con tutti i membri del SIEF che non partecipano al consorzio o all’accordo. Ulteriori informazioni sulle forme di cooperazione sono disponibili negli Orientamenti sulla condivisione dei dati: http://echa.europa.eu/it/guidance‑documents/guidance‑on‑reach

Si può abbandonare un forum per lo scambio di informazioni sulle sostanze (SIEF)?

Un SIEF non si può abbandonare; l’utente rimane membro del SIEF anche se la propria società interrompe le attività relative alla sostanza, ed è tenuto a condividere le informazioni in suo possesso in conformità alle disposizioni del REACH in materia di condivisione dei dati. Non è però tenuto a prendere parte a una presentazione (o ad un aggiornamento) effettuati dai membri del SIEF, né a concorrere a ulteriori spese connesse.

Durante la fase pre-SIEF è possibile disattivare la propria adesione al pre-SIEF nel sistema REACH-IT per indicare che non si è interessati alla registrazione della sostanza. È possibile che, anche in qualità di membro non attivo, l’utente sia tenuto a condividere i propri dati.

È necessario diventare membro di un forum per lo scambio di informazioni sulle sostanze (SIEF) se si intende registrare una sostanza soggetta a un regime transitorio?
Sì e, nella pratica, REACH-IT inserisce automaticamente l’utente che ha effettuato la registrazione preliminare di sostanze soggette a un regime transitorio con lo stesso nome o con gli stessi identificatori chimici di altri dichiaranti potenziali nello stesso pre-SIEF. Un SIEF si costituisce quando i dichiaranti intendono preregistrare di comune accordo la stessa sostanza.

Se si registra una sostanza soggetta a un regime transitorio anteriormente al 1° giugno 2018 senza averla preregistrata in precedenza, occorre indicare anche il SIEF corrispondente.

Se si è un dichiarante potenziale di una sostanza soggetta a un regime transitorio senza averla tuttavia preregistrata, è necessario trasmettere una richiesta all’ECHA. Per informazioni sui partecipanti al forum per lo scambio di informazioni sulle sostanze (SIEF) e sui loro obblighi, consultare gli Orientamenti sulla condivisione dei dati: http://echa.europa.eu/it/guidance-documents/guidance-on-reach
Qual è il ruolo dell’ECHA nella formazione di un forum per lo scambio di informazioni sulle sostanze (SIEF)?

L’ECHA non ha alcun ruolo nella formazione dei SIEF, né conferma o rifiuta la creazione di un SIEF specifico; spetta ai membri del forum la responsabilità di definire precisamente la sostanza per la quale sarà costituito un SIEF.

In cosa differiscono i ruoli di facilitatore della formazione del SIEF (SFF, ossia SIEF Formation Facilitator) e di dichiarante capofila?

Il facilitatore della formazione di un SIEF (SFF) non è formalmente riconosciuto dal regolamento REACH, mentre il ruolo di dichiarante capofila è specificatamente previsto e necessario per le registrazioni congiunte; ne consegue che i potenziali dichiaranti non sono obbligati ad avvalersi di un SFF per formare un SIEF e, se l’SFF non interviene, possono anche farne a meno al fine di avviare le discussioni pre-SIEF. Per contro, il SIEF deve scegliere un dichiarante capofila che presenti la registrazione congiunta prima che gli altri dichiaranti che partecipano al SIEF possano presentare i propri fascicoli singoli ("fascicoli dei membri") per la registrazione.

Ulteriori indicazioni sul ruolo dell’SFF sono reperibili negli Orientamenti sulla condivisione dei dati: http://echa.europa.eu/it/guidance-documents/guidance-on-reach.

Se si riceve una richiesta da un facilitatore della formazione di un SIEF che chiede il pagamento di un compenso, occorre soddisfare tale richiesta?

Un facilitatore (SFF) non può chiedere un compenso per i servizi offerti, a meno che ciò non sia stato stabilito di comune accordo. Il suo compito dovrebbe essere quello di contattare gli altri partecipanti al pre-SIEF al fine di agevolare lo scambio di informazioni e di dati necessario per formare un SIEF. Gli SFF non svolgono un ruolo direttivo, ma si limitano a favorire le discussioni; inoltre non hanno la facoltà giuridica per obbligare gli altri partecipanti al pre-SIEF a collaborare con loro.

L’ECHA può fare qualcosa per aiutare i forum per lo scambio di informazioni sulle sostanze (SIEF) a condividere i dati per sostanze diverse?

Poiché gli obblighi di condivisione dei dati (e di presentazione congiunta) previsti dal regolamento REACH riguardano solo le registrazioni della stessa sostanza da parte di più dichiaranti, non esiste un meccanismo giuridico che obblighi SIEF diversi a condividere i dati. Tutte le richieste di accesso a studi tra SIEF diversi dovranno essere negoziate caso per caso dalle società interessate. Ulteriori indicazioni sulle regole inter-SIEF sono disponibili nella sezione 3.2.7 - "Regole inter-SIEF (raggruppamento, read-across)" degli Orientamenti sulla condivisione dei dati: http://echa.europa.eu/it/guidance-documents/guidance-on-reach.

Che cosa è possibile fare se viene individuata una lacuna dei dati nel proprio SIEF e nessuno è disposto a condurre il nuovo test sperimentale?

Se i membri del SIEF non riescono ad accordarsi su chi svolgerà il nuovo test (per mancanza di volontari o per la presenza di più di un volontario), possono effettuare una richiesta all’ECHA (https://comments.echa.europa.eu/comments_cms/article302.aspx) affinché designi un dichiarante per lo svolgimento del test. L’ECHA, in base a criteri oggettivi, selezionerà il dichiarante che condurrà lo studio.

Per quanto riguarda il termine di registrazione del 2018, è prevedibile che la selezione avverrà nella maggior parte dei casi in modo casuale per via della mancanza di differenze significative tra i dichiaranti potenziali.

Una volta effettuato il test sperimentale, tutti i membri del SIEF che hanno richiesto lo studio contribuiranno ai relativi costi con la quota corrispondente al numero di dichiaranti potenziali partecipanti.

Questa procedura si applica alle situazioni in cui i membri del SIEF concordano sulla necessità del test, ma non se i membri sono in disaccordo sul fatto che la sperimentazione sia indispensabile o giustificata.
Ulteriori ragguagli sono disponibili nella sezione 3.4.1 degli Orientamenti sulla condivisione dei dati (https://echa.europa.eu/documents/10162/13631/guidance_on_data_sharing_it.pdf).

Cosa occorre fare se non si intende rivelare la propria identità ai propri concorrenti nell’ambito di un SIEF?

È possibile nominare un rappresentante terzo (TPR) per essere rappresentati nella trasmissione congiunta e nelle attività di condivisione dei dati.

NB: in termini legali il fabbricante o l’importatore continua a essere il dichiarante o il dichiarante che esegue la preregistrazione. Il TPR non deve essere confuso con le terze parti che detengono informazioni (ossia i titolari dei dati) né tantomeno con un rappresentante esclusivo.

Per maggiori informazioni, consultare gli Orientamenti sulla condivisione dei dati, sezione 3.2.3.1. Nella Q&A 352 viene spiegato come assegnare un TPR nel sistema REACH-IT.

Cosa succede se non si intende partecipare attivamente alle discussioni del SIEF?

Si può indicare ai co-dichiaranti nel sistema REACH-IT il proprio ruolo passivo; tuttavia è possibile che all’utente venga richiesto comunque, anche se è un membro non attivo del pre-SIEF, di condividere i propri dati nel forum.

La disattivazione del pre-SIEF nell’ambito di REACH-IT non pregiudica l’obbligo di preregistrazione e di registrazione. È necessario registrare la sostanza se si prevede di continuare a fabbricarla e importarla in quantitativi superiori a una tonnellata all’anno dopo il termine di registrazione del 2018.

Quand’anche si svolga un ruolo passivo durante le attività del SIEF, si condivide la responsabilità dei dati trasmessi nell’ambito di una registrazione congiunta. Pertanto occorre capire i dati e concordarli con i propri co-dichiaranti pur non essendo attivamente impegnati nella loro compilazione.

Per maggiori informazioni sulla disattivazione nel sistema REACH-IT, consultare la Q&A 347.

Se è stata effettuata la preregistrazione, ma è stata interrotta la fabbricazione o l’importazione prima della scadenza, si è ancora soggetti ad obblighi?

Una volta effettuata la preregistrazione, l’utente entra a far parte del SIEF relativo alla sostanza e altri membri del SIEF possono richiedergli informazioni ai fini della registrazione. Se si è in possesso di tali informazioni, si è tenuti a fornirle su richiesta e, ove applicabile, è prevista una compensazione finanziaria.

C. Condivisione dei dati e relativa richiesta

Come si accede a dati presentati più di 12 anni fa per notifiche ai sensi della direttiva 67/548/CEE?

Quando si presenta una richiesta, occorre indicare i dati previsti per la fascia di tonnellaggio che si intende registrare.

Si otterrà quindi accesso alla pagina dei co-dichiaranti in REACH-IT, che contiene informazioni sui dichiaranti precedenti e potenziali (richiedenti), nonché alle informazioni riguardanti altri potenziali dichiaranti che sono membri del pre-SIEF, ossia che hanno effettuato la pre-registrazione (tardiva) ma non hanno ancora effettuato la registrazione.

Inoltre, l’ECHA specifica se vi sono dati che sono stati presentati più di 12 anni prima.

È importante distinguere la data di presentazione dalla data di esecuzione dello studio, che precede la presentazione stessa. La regola dei 12 anni si applica a partire dal momento in cui viene presentato lo studio specifico, indipendentemente da quando è stato eseguito.

Inoltre, la data di presentazione all’autorità competente del risultato di un test specifico non corrisponde necessariamente alla data originale della sua notifica.

Infatti il test potrebbe essere stato presentato successivamente (per esempio in seguito a un aumento della fascia di tonnellaggio con conseguente passaggio al livello successivo di sperimentazione), per cui il periodo di 12 anni potrebbe non essere ancora terminato. Per maggiori informazioni, consultare i nuovi Orientamenti sulla condivisione dei dati (attualmente disponibili sotto forma di progetto), sezione 4.6.1. La «regola dei 12 anni»

I sommari di studio o i sommari esaurienti di studio presentati nell’ambito di una registrazione della stessa sostanza ai sensi del regolamento REACH almeno 12 anni prima vengono allegati alla comunicazione dell’ECHA inviata al richiedente. Tuttavia, le informazioni fornite dall’ECHA nelle sintesi degli endpoint potrebbero non essere sufficienti per superare il controllo di completezza tecnica (TCC) perché:

  • alcuni dati non sono migrati nel formato IUCLID richiesto e dovranno essere corretti manualmente e/o
  • in alcuni campi o sezioni potrebbero mancare talune informazioni amministrative.

Analogamente, il dichiarante potenziale deve valutare la qualità dei dati forniti. Può essere necessario contattare il dichiarante precedente per

chiedere maggiori dettagli o valutare l’ipotesi di ricorrere ad altre fonti per ottenere informazioni migliori, se la qualità è troppo bassa.

L’ECHA inoltre comunica ai precedenti dichiaranti che è stata presentata una richiesta relativa a una delle loro sostanze.

Se si è interessati a ricevere dati presentati più di 12 anni fa per applicare il metodo del read-across, è possibile rivolgersi all’ECHA per richiederli, conformemente all’articolo 25, paragrafo 3. Si fa notare che i richiedenti sono tenuti a:

  1. dimostrare la propria reale intenzione di effettuare una registrazione o aggiornare il fascicolo di registrazione, fornendo all’ECHA i numeri di preregistrazione, i numeri di registrazione o di richiesta e il numero CE delle proprie sostanze;
  2. fornire una spiegazione dei motivi per i quali si necessita dei dati e del modo in cui si intende utilizzarli (ad esempio per applicare il metodo del read-across);
  3. presentare una dichiarazione in cui si precisi che «i dati forniti saranno utilizzati esclusivamente a fini di registrazione a norma del regolamento REACH»;
  4. elencare gli endpoint per i quali si necessita di informazioni.

Inoltre, si fa notare che l’accesso ai dati non conferisce la proprietà degli stessi. Ai sensi del regolamento REACH, i dati risalenti a più di 12 anni prima possono essere utilizzati esclusivamente ai fini della registrazione.

Perché occorre eseguire una richiesta?
Qualsiasi dichiarante potenziale di una sostanza non soggetta a un regime transitorio o di una sostanza soggetta a un regime transitorio non pre-registrata ha l’obbligo di chiedere all’ECHA se è già stata effettuata una registrazione per la stessa sostanza (articolo 26 del regolamento REACH). Anche un dichiarante che desideri
aggiornare il suo fascicolo dovrà preventivamente inviare una richiesta (articolo 12, paragrafo 2, del regolamento REACH). Questo obbligo legale assicura che i dati vengano condivisi dalle parti interessate e che gli esperimenti sugli animali non vengano ripetuti quando non è necessario.
La richiesta e il suo esito dipenderanno dal fatto che gli eventuali dati relativi a una registrazione precedente siano stati presentati più o meno di 12 anni prima della data della richiesta.
Figura 1:
Figura 1: processo di condivisione dei dati in seguito a una richiesta
Per ulteriori ragguagli sulla procedura di richiesta consultare il sito web dell’ECHA all’indirizzo: http://echa.europa.eu/regulations/reach/substance-registration/inquiry
Che cosa succede una volta presentata la richiesta, per quanto riguarda la condivisione dei dati?
Dopo la presentazione della richiesta, l’ECHA comunicherà al dichiarante potenziale se la sostanza è già stata registrata (o notificata ai sensi della direttiva 67/548/CEE concernente la classificazione, l’imballaggio e l’etichettatura delle sostanze pericolose). In tal caso, l’ECHA comunicherà al dichiarante potenziale nomi e indirizzi dei precedenti dichiaranti ed eventualmente di altri richiedenti. Questa comunicazione consentirà al dichiarante potenziale di richiedere la condivisione dei dati esistenti.
Se il dichiarante potenziale, al momento della richiesta, non ha elencato gli endpoint necessari alla registrazione, l’ECHA comunicherà solo l’identità dei precedenti dichiaranti. Se il dichiarante potenziale ha indicato nella richiesta all’ECHA le prescrizioni in materia d’informazione a lui applicabili, l’ECHA fornirà inoltre l’elenco dei sommari (esaurienti) di studio
già presentati.
- Studi presentati almeno 12 anni prima (cfr. la successiva domanda 2.3): l’ECHA indicherà nella sua risposta se siano stati presentati sommari (esaurienti) di studio almeno 12 anni prima della data della richiesta. In tal caso, il dichiarante potenziale può chiedere all’ECHA di fornire una copia di tali studi, che potrà essere usata a scopo di registrazione dal dichiarante potenziale (articolo 26 del regolamento REACH).
- Studi presentati meno di 12 anni prima (cfr. Q&A ID=424):
il dichiarante potenziale dovrà chiedere direttamente ai dichiaranti precedenti i sommari (esaurienti) di studio necessari alla registrazione. È obbligatorio presentare una richiesta per qualsiasi studio su animali vertebrati. È comunque possibile presentare richieste anche per studi che non coinvolgono animali vertebrati.
Cosmetici

When can an adaptation of the information requirements under REACH be exercised by a Registrant, in case the substance is used in cosmetic products in the EEA?

In general, testing for human health endpoints can be adapted (‘waived'), if the substance is used in the EEA exclusively in cosmetic products falling within the scope of the Cosmetics Regulation, and if the testing would not be necessary to fulfil the REACH requirements for the assessment of worker exposure.

Two main scenarios are foreseen where cosmetics-based waiving could be applied. 

  • In cases where imported products fall within the scope of the Cosmetics Regulation (EC No 1223/2009) and which, from the time of import, are neither further processed nor repackaged inside the EEA, an adaptation of animal testing requirements for human health endpoints can be sought, based on the absence of relevant worker exposure;  
  • In other cases, you may be able to seek an adaptation of an information requirement by demonstrating that the substance is handled under strictly controlled conditions during all stages of the life-cycle, other than the use as a cosmetic product (i.e. manufacture, formulation and/or packaging stage).  

In all circumstances, you shall provide a reasoned justification for requesting the waiver.

If a chemical is only used in a cosmetic product, and if there is a potential for worker exposure during the manufacturing process, will testing on animals be required under REACH?

Where exposure to workers in the EEA is established, the REACH requirements apply. Note that the REACH provisions under Annexes VII to XI encourage the use of adaptations; animal testing should be performed as a last resort only (Article 25 of REACH).

Consequently, testing on vertebrate animals will be required only if there is no available information which meets the information requirements, and where no adaptation possibility under column 2 of REACH Annexes VII to X, or under Annex XI can be applied.

This will represent the only means to assess the potential human health risks arising from exposure to workers. 

In practice, how can an adaptation of an information requirement be exercised by a Registrant where the substance is solely used in cosmetics?

As for every adaptation of an information requirement in a registration dossier, you need to insert a justification in each of the relevant endpoints of the IUCLID dossier.

Two main types of scenarios have been identified:

  1. Where the substance is imported into the EEA in a cosmetic product that is not further processed in the EEA: in addition to following the instructions provided by ECHA (see below), you shall add, to the respective endpoint(s) in IUCLID, an explanatory note stating that the substance is solely used in cosmetics, imported in the finished state and not further processed nor repackaged inside the EEA;
  2. Where the substance/cosmetic product is further processed in the EEA, but where absence of worker exposure can be demonstrated: you may avail yourself of the regular adaptation possibilities, pursuant to Annex XI, section 3.1 of REACH, to waive the testing requirements addressed by sections 8.6 and 8.7 (repeated dose toxicity and reproductive toxicity respectively) of Annex VIII to REACH and the test in Annex IX and X.

When applying these adaptations, for the purpose of the justification required according to Annex XI, section 3.2, you do not need to consider the life-cycle stages related to the use of the finished cosmetic product, as these are regulated separately under the Cosmetics Regulation.

While testing for acute toxicity cannot normally be waived under Annex XI, section 3.2, for the purpose of registrations dossiers that cover only cosmetic uses, a similar waiver containing the elements of Annex XI, section 3.2 may be used for this endpoint.

See section 5.1 of the Guidance on information requirements and chemical safety assessment, Chapter R.5: Adaptation of information requirements for further details on how to make use of this adaptation possibility.

Furthermore, ECHA provides further specific recommendations to follow below when you create or update your registration dossier.

How can a Registrant indicate the request for adaptation of information requirements for human health endpoints in the IUCLID dossier if the substance is imported and not further processed in the EEA?

In IUCLID 6, a request for ‘waiving' a standard information requirement under REACH must be recorded in the fields ‘Data waiving' and a ‘Justification for data waiving' must be recorded for each endpoint where waiving is proposed. Please follow the instructions below when you create or update your registration dossier.

The description of the information to be provided has been organised by ‘IUCLID Section' and ‘Field'. In addition, a distinction has been made between the information to be entered in the substance dataset, and information that can only be entered when you create the dossier.

Please use from the column "Selection/ entry" the appropriate pick-list selection and the recommended standard text to be entered in the corresponding ‘Field'.

If the substance is only imported in the EEA in a cosmetic product in its final state (neither further processed nor repackaged inside the EEA), the waiving possibility is only relevant for human health endpoints and is only based on the fact that there are no uses in any stage of the life-cycle which may be relevant to REACH (no exposure to workers; exposure to professionals and consumers is covered by the Cosmetics Regulation).

The following specific data waivers can be used only for human health information requirements (Sections 8 of REACH Annexes VII-X).

 

 

IUCLID section

Field

Selection / entry

Substance dataset

Any Endpoint Study Record– Annexes VII to X *

Data waiving

’study waived due to provisions of other regulation’

Justification for data waiving

‘other:’ + “The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. See field ‘Justification for type of information’ for further details.”

Justification for type of information

The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is imported in a cosmetic product in its final state (i.e. the product is from the time of import neither further processed nor repackaged inside the EEA).

Waiving of animal testing requirements for human health endpoints is proposed based on the absence of uses other than in finished cosmetic products.

Section 3.5.5 – Consumer uses **

Product category ***

PC39

Dossier

Dossier header

Dossier submission remark

“This dossier covers a substance that is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is imported in a cosmetic product in its final state. The product is from the time of import neither further processed nor repackaged inside the EEA.” 

Updates only

Dossier header

Spontaneous update, ‘Justification' ****

‘other' +  ”Cosmetics Regulation / 2013

* Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier.
** The information to be provided for each use, entered in IUCLID section 3.5.5: Consumer uses, is described in the manual How to prepare registration and PPORD dossiers (Chapter 9.6.4.3 and Annex 2). The manual is available on the ECHA website (under Support > Manuals), as well as inside the IUCLID 6 Help system.
***All uses outside the cosmetic use have to be documented in Section 3.5

**** A separate justification should be entered for each reason for the update.

How can a Registrant indicate an adaptation of information requirements for human health endpoints in the IUCLID dossier if the substance is imported and further processed in the EEA, without exposure to workers?

In IUCLID 6, a request for ‘waiving' a standard information requirement under REACH must be recorded in the fields ‘Data waiving' and a ‘Justification for data waiving' must be recorded for each endpoint where waiving is proposed. Please follow the instructions below when you create or update your registration dossier.

The description of the information to be provided has been organised by ‘IUCLID Section' and ‘Field'. In addition, a distinction has been made between the information to be entered in the substance dataset, and information that can only be entered when you create the dossier. Please use from the column "Selection/ entry" the appropriate pick-list selection and the recommended standard text to be entered in the corresponding ‘Field'.

If the substance is further processed inside the EEA, i.e. it is imported or manufactured in the EEA, and still further formulated or re-packaged, before or after inclusion in the final cosmetic product, you need to demonstrate the absence of exposure to workers to benefit from the adaptation possibility.

This case also covers situations where you do not need to provide an exposure assessment: either no CSR is required due to the low tonnage of the substance manufactured or imported, or no exposure assessment is required because the substance does not require classification.

Consequently, you should document the absence of exposure as appropriate, using exposure scenarios and/or other approaches. You can apply for the following specific data waivers, specifically for the human health information requirements (Sections 8 of REACH Annexes VII-X).

 

IUCLID section

Field

Selection / entry

Substance dataset

Endpoint Study Record corresponding to: *

-Annex VII

-Annex VIII (except sections 8.6 and 8.7)

Data waiving

‘study waived due to provisions of other regulation’

 

Justification for data waiving

‘other:’ + “The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. See field ‘Justification for type of information’ for further details.”

 

Justification for type of information

The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and/ or further processed inside the EEA before/ after inclusion in the final cosmetic product.

Waiving of animal testing requirements for human health endpoints is proposed, since the substance is handled only under strictly controlled conditions, with the exception of the life-cycle stage that covers the use as a cosmetic product (for which the safety assessment is done under the Cosmetics Regulation). Where it is demonstrated that the substance is handled according to strictly controlled conditions (see, as an example, REACH Annex XI, Section 3(2)(b)), during all life-cycle stages, with the exception of the use as a cosmetic product, the absence of exposure to workers is documented in IUCLID section 13:”
<registrant to choose the appropriate option(s)>

  • in the exposure scenario of the CSR.
  • in an assessment report (if no exposure scenario is required).

 

Endpoint Study Record corresponding to: *

-Section 8.6 and 8.7 of

 Annex VIII
-Annex IX
-Annex X

Data waiving

‘exposure considerations'

 

Justification for data waiving

‘other:’ + “The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. See field ‘Justification for type of information’ for further details.”

 

Justification for type of information

“The substance is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and/ or further processed inside the EEA before/ after inclusion in the final cosmetic product.

Waiving of animal testing requirements for human health endpoints is proposed since the substance is handled only under strictly controlled conditions, with the exception of the life-cycle stage that covers the use as a cosmetic product (for which the safety assessment is done under the Cosmetics Regulation). Where it is demonstrated that the substance is handled according to strictly controlled conditions (see, as an example, REACH Annex XI, Section 3(2)(b)), during all life-cycle stages, with the exception of the use as a cosmetic product, the absence of exposure to workers is documented in IUCLID section 13:
<registrant to choose the appropriate option(s)>

  • in the exposure scenario of the CSR.
  • in an assessment report (if no exposure scenario is required).

 

Section 3.5.5 – Consumer uses **

Product category ***

PC39

 

       

 

Dossier

Dossier header

Dossier submission remark

“This dossier covers a substance that is used exclusively in cosmetic products which fall within the scope of the Cosmetics Regulation. The substance is manufactured and /or further processed inside the EEA before/ after inclusion in the final cosmetic product. All manipulation of the substance outside the cosmetics use takes place under strictly controlled conditions.”

 

Updates only

Dossier header

Spontaneous update, ‘Justification' ****

‘other:' + “Cosmetics Regulation / 2013”

 

 

*Data waiving can only be applied to the endpoints required by the REACH Annexes for the tonnage band corresponding to the registration dossier.
**The information to be provided for each use, entered in IUCLID section 3.5.5: Consumer uses, is described in the manual How to prepare registration and PPORD dossiers (Chapter 9.6.4.3 and Annex 2). The manual is available on the ECHA website (under Support > Manuals), as well as inside the IUCLID 6 Help system.
***All uses outside the cosmetic use have to be documented in Section 3.5.

**** A separate justification should be entered for each reason for the update.

See also: https://echa.europa.eu/documents/10162/13628/reach_cosmetics_factsheet_en.pdf

I received a decision under REACH imposing the requirement to provide information performing an animal test. The decision was adopted before March 2013 and I have not yet started the test. Am I still required to comply with the decision?

Yes, the ECHA decision is legally valid and binding, so you have to comply with it.

However, if the substance is used exclusively in a cosmetic product and falls under one of the scenarios described, i.e. animal testing would only serve the purpose to address human health risks resulting from the exposure to the finished cosmetic product, you should be able to comply with the decision you received by requesting use of waiving possibilities, as per the REACH Annexes.

Illustration of cosmetics-based waiving scenarios.

It is only where the required testing relates to potential human health effects for workers that animal tests may be required. In such circumstances, the tests are performed to meet the requirements of REACH.

Does the entry into force of the total marketing ban for animal tested cosmetic products/ingredients affect the compliance of the registration dossiers I already submitted?

No, the entry into force of the total marketing ban under the Cosmetics Regulation (EC) No 1223/2009 does not influence the REACH requirements.

However, if your registered substance is exclusively used in cosmetics, ECHA recommends that you spontaneously update your registration dossier to clearly indicate the uses, should you wish ECHA to take this into account in any subsequent examination. Please follow the instructions provided according to the scenarios described in Q&A 991.

If you have not registered your substance already, ECHA recommends that you follow the instructions provided according to the scenarios described in Q&A 991.

Where do I find more information on the Cosmetics Regulation and the animal testing/marketing ban?
  • For more information regarding the Cosmetics Regulation and the requirements therein, please visit theEuropean Commission website
  • For more information on the interface of REACH and the Cosmetics Regulation, you may consult the factsheet ECHA has published in consultation with the European Commission.
  • You may also contact the ECHA Helpdesk.
Dichiaranti NONS di sostanze precedentemente notificate

How do I prepare IUCLID 6 dossier in case of a NONS update?

A distinction should be made between updates due to a tonnage band change, becoming a lead of a joint submission and other updates.

For a NONS registration update due to increase in the tonnage band or becoming a lead of a joint submission, a complete dossier in IUCLID 6 format has to be submitted to ECHA like for any other standard or transported isolated intermediate registration.

For other NONS updates, certain information is not required and may be waived until the next tonnage threshold is reached, provided that explanatory derogation statements are included in the dossier header.

In order to successfully update your registration dossier you should follow the steps outlined below:

  1. Migrate the SNIF file to IUCLID 5.6 and then import it to IUCLID 6 You can request your notification migrated into IUCLID format (IUCLID substance dataset) from your relevant Member State Competent Authority, or migrate it yourself using the SNIF migration plug-in tool available on the IUCLID web site http://iuclid.echa.europa.eu/.
  2. Update the substance dataset according to the REACH requirements. Please note that all registration updates undergo a technical completeness check according to the requirements of Article 20(2) of the REACH Regulation. You are advised to first check your tonnage band in REACH-IT, as described in Q&A 686.

    To be considered as complete, your dossier should be filled-in as specified below:
    • When updating a dossier due to an increase of tonnage band or becoming a lead of a joint submission, the registrant must be aware that the updated dossier must fully comply with all REACH information requirements. The update should not only contain the information required by REACH which corresponds to that higher tonnage threshold, but also any information which corresponds to lower tonnage thresholds. If your update involves a registration at or above the 10 tonnes threshold, a complete chemical safety report (CSR) should be included in section 13 of your IUCLID 6 dossier unless the conditions for not submitting a CSR as set out in Article 14(2) of the REACH Regulation are met (in which case a justification should be provided in section 13 instead).

      For further information please consult the manual "How to prepare registration and PPORD dossiers" at: http://echa.europa.eu/manuals.

    • For updates to include the classification and labelling according to the CLP Regulation. You have to update your registration dossier to include the classification and labelling according to Regulation (EC) No 1272/2008 (‘CLP Regulation') in case you manufacture or import your NONS substance in a volume of more than or equal to 1 tonne per year. For NONS notified below 1 tonne under Directive 67/548/EEC and for which no tonnage band update has been done, a separate notification to the Inventory will have to be made, and the registration dossier does not need to be updated.
    • If you only need to update the classification and labelling but your tonnage band remains unaltered, you only need to provide a minimum of information as explained in Annex 4 of "How to prepare registration and PPORD dossiers" manual " available at: http://echa.europa.eu/manuals.

    • For updates to the joint submission status of the claimant, select an appropriate dossier template for your submission.

      The lead of a joint submission uses a standard template accordingly to the tonnage band covered by the joint submission. The tonnage band of the lead registrant is indicated in the dossier header.

      Members of a joint submission need to select a special template for a joint submission member. Two different kinds of member templates exist: general registration and intermediate registration. Intermediate template is used if the member registers only an isolated intermediate (transported or on-site).

      When creating the dossier, the tick box ‘Joint submission' must be ticked in the dossier header. When submitting the dossier in REACH-IT, the submitter must select ‘joint submission:' and provide the name of the joint submission.

    • For other types of updates, Other updates concern all other cases indicated under Article 22(1) of the REACH Regulation and updates following a decision made by the MSCA according to Article 16(1) or 16(2) of Directive 67/548/EEC. For such updates, the dossier does not need to include information requested under the REACH Regulation that was not required under the previous legislation (i.e. Directive 67/548/EEC).. The minimum information which needs to be submitted in these types of updates (when the tonnage band remains unaltered) is provided in Annex 4 of "How to prepare registration and PPORD dossiers" manual " available at: http://echa.europa.eu/manuals.
    IMPORTANT NOTE:
    • In Section 1.3 ‘Identifiers' of your IUCLID 6 dossier, do not forget to specify your notification number under Directive 67/548/EEC, as well as your reference number under the REACH Regulation (the one you received when claiming your NONS via REACH-IT).
    • In Section 1.7 ‘Suppliers' of your IUCLID 6 dossier, do not forget to attach all necessary contractual agreements if you are representing a non-Community manufacturer.
  3. Update your confidentiality claims.

    In case you wish to keep confidential the information which was accepted as such under Directive 67/548/EEC, you are required to write in the justification field adjacent to each confidentiality flag the text ‘Claim previously made under Directive 67/548/EEC'. This will allow ECHA to invoice correctly and validate the claims already presented under Directive 67/548/EEC. confidentiality

    Please note that ECHA will only charge a fee for those confidentiality claims associated with new information submitted, or new confidentiality claims for existing information. This means that there will be no fee for confidentiality claims successfully made under Directive 67/548/EEC, provided that this is confirmed by the registrant in their dossier as indicated above.

    Please note that the information listed below could not be claimed confidential under Directive 67/548/EEC.

    • The name of the notifier (which under REACH is considered to be part of the information contained in the safety data sheet).
    • The information contained in the safety data sheet (including registration number, uses and uses advised against).
    • The trade name of the substance.
    • If essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous.

    For these claims, a full justification needs to be provided and the claim will be subject to the corresponding fee under REACH.

    Please be aware that dissemination of information listed in Article 119(1) of the REACH Regulation includes the IUPAC names of substances included in Annex I to Directive 67/548/EEC and that, as a general rule, information listed both in Articles 119(1) and 119(2) of the REACH Regulation will be disseminated.

    ECHA will not disseminate the information listed in Article 119(2) for which a party has submitted a justification, accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned.

    More information about the confidentiality claims which are possible under REACH is available in the document "Dissemination and confidentiality under the REACH Regulation" at: http://echa.europa.eu/manuals.

    You are able to simulate which information from your dossier will be made available on the ECHA website by using the dissemination tool available in IULID 6

  4. Create the IUCLID registration dossier

    Once you have prepared your substance dataset, you need to create your registration dossier. To do this:

    • Choose the correct IUCLID Template. Make sure that the template selected corresponds with the intended submission Further information in "How to prepare registration and PPORD dossiers " manual available at http://echa.europa.eu/manuals.
    • Complete the dossier header information. For the specific case of NONS registration updates, you have to fill in the dossier header in IUCLID in the following way (see also screenshot below):
      • Tick the box "Is the submission an update?".
      • Indicate the submission number in the "Last submission number" field (the one you received when you claimed your registration number via REACH-IT) .
      • Tick the box "Spontaneous update".
      • Select the justification of the update. If there is more than one reason for your spontaneous update (e.g. change of tonnage band and change of classification and labelling), you should create several repeatable blocks under ‘Spontaneous update'.
      Please remember that in case of NONS substances notified below 1 tonne and for which no tonnage band update has been done, you need to submit a ‘C&L notification' instead of an update of your registration dossier.

Please remember that in case of NONS substances notified below 1 tonne and for which no tonnage band update has been done, you need to submit a ‘C&L notification' instead of an update of your registration dossier.

Other types of updates. In case of other types of spontaneous updates, you will have to select the proper justification. If you select ‘other', indicate clearly the reason for updating in the adjacent field.

For the specific case of an update according to Article 135 of the REACH Regulation (Transitional measures regarding notified substances), select ‘other' in the justification field and indicate the new information that you are updating in the free text field: "Article 135 of REACH – submission of test (specify test)".

Specific Submissions

Once you have created your IUCLID dossier, you need to submit it through REACH-IT. See Instructions in "How to prepare registration and PPORD dossiers" manual at: http://echa.europa.eu/manuals.

In the case that you are an Only Representative representing several non-Community companies under the REACH Regulation you need to submit a separate updated registration for each of the non-Community manufacturers you represent.

For a tonnage band increase (and only in this case). Before you submit your registration update you are required to inform ECHA of the additional information you would need to comply with the information requirements for the new tonnage level (Article 12(2) of the REACH regulation). In order to facilitate this process, you are required to submit an inquiry to ECHA. Upon receipt of this information, ECHA acts as in the inquiry process (Article 26(3) and (4) of the REACH Regulation) and will inform the registrant of the names and addresses of any previous registrants (and any potential registrants) and of any relevant study summaries already submitted by them. The purpose for this is to share existing data and to ensure that studies on vertebrate animals are not unnecessarily repeated. The inquiry for a tonnage band increase should be submitted according to the procedures outlined in the manual "How to prepare and submit an inquiry" at: http://echa.europa.eu/manuals.

 

How do I claim a registration number for a notified substance?

According to Article 24 of the REACH Regulation all notified substances under Directive 67/548/EEC (NONS) are considered already registered under the REACH Regulation at the relevant tonnage band.

A notification under Directive 67/548/EEC is nominal so that only the notifier benefits from his notified substance as being considered registered (Cf. Section 1.6.5.3 of the Guidance on Registration available at: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation).

In principle, any other parties intending to manufacture or import a notified substance but who have not notified such substance themselves cannot be assigned a registration number under Article 24 of the REACH Regulation. Such parties should submit an inquiry and subsequently register the substance in accordance with the provisions of the REACH Regulation. The European Chemicals Agency (ECHA) has assigned registration numbers to all notifications made in accordance with Directive 67/548/EEC.

These registration numbers can be requested from ECHA by the owner of the notification via the REACH-IT system using the "Claim Notified Substances" module. This procedure will confirm to ECHA the identity of the notifier and to whom the registration number should be sent to. In addition, the REACH-IT database will be updated with the latest contact details of the notifiers, which will also enhance the data-sharing process.

If the claimant's details specified in REACH-IT match those for the notification, ECHA will provide the registration number. If the claimant's details do not match, ECHA will not be able to allocate any registration number and the notifier is advised to contact its relevant Member State Competent Authority (MSCA) to resolve this issue. Claimants need to sign-up in REACH-IT for each type of role they had under Directive 67/548/EEC for the notified substance in question.

There are four potential types of claimant (role) that may request a registration number for a notified substance:

  • The claimant was a Domestic Manufacturer under Directive 67/548/EEC (i.e. the Manufacturer was established within EU).
  • The claimant was an Importer under Directive 67/548/EEC.
  • The claimant was a Sole Representative under Directive 67/548/EEC.The claimant is a newly appointed Only Representative and will take the duties of a previous notifier (Sole Representative). Note that Only Representatives must sign up in REACH-IT for each non-community manufacturer they represent and submit a claim using the appropriate account.

    It is not possible to use the same legal entity object (having the same company UUID) for multiple accounts, but it is possible to use the same company identification information (name, VAT, etc.). In case of a Sole Representative or newly appointed Only Representative, one registration number will be allocated per non-Community manufacturer represented. The claimant will have to submit, in REACH-IT, written evidence of the validity of his request. This provision is in line with the implementation already in place for an Only Representative in case of registration.

 

How do I request a registration number for my notified substance?

Once you have signed-up in REACH-IT and specified your company details, you can proceed with the request of your registration number. The distribution of registration numbers by ECHA will be made following your request via the "Claim Notified Substance" module in REACH-IT.

  • Log-in to REACH-IT >> Menu >> Registration >> Claim notified substance
  • Put the Notification number (standard format) without the 2 last digits corresponding to the version of the notification (you should specify XX-XX-XXXX in REACH-IT). And Put the ELINCS number of the notified substance and follow the wizard

If all the information specified is correct and matches with that in the notification dossier:

You will instantly receive a submission number, and a reference number via REACH-IT. You can request for the notification to be migrated in IUCLID 6 format from your relevant Member State Competent Authority. You can find their contacts at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities.

If the information specified does not match with that in the notification, ECHA will not be able to allocate the registration number to you. You are advised to contact your relevant Member State Competent Authority to resolve the situation. You can find their contacts at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities.

How many NONS registration numbers will I receive for my role(s)?

Depending on your role(s), you will usually only receive one registration number. The table below highlights the combinations of roles and indicates the corresponding number of requests and registration numbers received.

combination of roles

What must I do in case of change of legal entity and transfer of my NONS notification to another company?

A notification under Directive 67/548/EEC is nominal so that only the notifier benefits from being considered registered according to Article 24 of the REACH Regulation. Cf. Section 1.6.5.3 of the Guidance on Registration available at: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation

Nevertheless, it may happen that a company with a legal personality that has notified a substance has transferred the responsibilities for manufacture and import of that substance to another company. In such circumstances the original notifier may have transferred its notification to the company that has taken over the original notifier's activities relating to the manufacture or import of the notified substance. Such an event may happen for example after a merger of two companies or, the company splits.

For instruction on the steps to take please consult "Practical guide 8: How to report changes in identity of legal entities" available at: http://echa.europa.eu/practical-guides

How do I verify the information recorded in REACH-IT for my notification

In a handful of cases, the New Chemicals Database (NCD) has not been adequately updated to reflect the current details for some notifications, in particular, for tonnage bands. As a result, this information may appear incorrectly in REACH-IT and the system may be unable to correctly accept a potential update of the registration dossier.

It is extremely important and very easy to check that the tonnage band of your notification is correctly indicated in REACH-IT before you submit any update of your registration dossier to ECHA to avoid potential delays in the submission process as a result of a business rules failure.

To confirm that the correct tonnage is indicated in REACH-IT:

  • Log in to REACH-IT >> Menu >> Search>>Reference numbers >> Search reference number using the criteria displayed Click on the Reference number link >> Tonnage band info is displayed under "Dossier type".

There are several tonnage bands mentioned in REACH-IT because under the REACH Regulation there are three possible registration types: standard registration, transported isolated intermediate (TII), and on-site isolated intermediate (OSII). Under Directive 67/548/EEC there was no such specific distinction and only one type of standard notification was required. All NONS notifications are initially regarded as standard registrations in REACH-IT. Therefore, your notified substance will initially not include any tonnage for isolated intermediates.

In the ‘Reference number' page you will also find under "Payment information" the tonnage band information which will be taken into account for invoicing purposes ( i.e. "Maximum tonnage band" and "Maximum transported isolated intermediate")

Paymrnt Information

Initially, here you will see the same tonnage bands indicated for the standard registration as for the transported isolated intermediate (TII). This is to ensure that ECHA does not charge fees for tonnage band updates in cases where this would not be legitimate.

In case you submit an update of your registration for a tonnage band that is different to what is reported in REACH-IT, you should select in your dossier header that the reason for the update is a change of tonnage band.

Who do I contact if the information in REACH-IT is not correct?

In case the information recorded in REACH-IT for your substance does not match with what was indicated in your notification, you will need to make a request for an amendment. This is achieved by contacting your relevant Member State Competent Authority, who will in turn confirm that an amendment is necessary and provide ECHA with the correct details.

You can find the contact details of all the Member State Competent Authorities at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities

How is the NONS information transferred from SNIF to IUCLID 5

Information for a notification under Directive 67/548/EEC was initially submitted to the Member State Competent Authority in the Summary Notification Interchange Format (SNIF). Thereafter, all the SNIF files were transmitted to the former European Chemicals Bureau (ex-ECB) at the Joint Research Centre. This information, stored in a central database called the new chemicals database (NCD) at the ex-ECB, was migrated into IUCLID 5 format and distributed back to the responsible Member State Competent Authority in 2 formats (read-only and editable).

Claimants (owners of the notification) should contact their Member State Competent Authority to receive their files in IUCLID 5 format. The editable format will enable them to fulfil their obligations under REACH, in particular when they need to update their registration in the case where the next tonnage threshold is reached.

The tool developed to migrate the SNIF file to IUCLID 5 format is also available to industry as an add-on to IUCLID 5 on the IUCLID web site http://iuclid.echa.europa.eu/. Please note though, the SNIF migration plug-in can only be used with IUCLID version 5.1.

In order to migrate to IUCLID 6, first migrate to IUCLID 5.1 and then import to 5.6 and after import to ICUID 6.

Please pay attention to the migrated file results and check the generated IUCLID 5 substance dataset carefully (e.g. Legal entity, confidentiality claims, endpoint study records, classification and labelling…) before using it for updating your registration via REACH-IT.

In which cases shall I update my NONS registration?

The registration dossier must be updated if at least one of the cases described in Article 22 or Article 24(2) of the REACH Regulation applies. This would also include any update referring to the inclusion of the information required under Article 40 of the CLP Regulation (notification to the Classification & Labelling Inventory).

It is important to verify the information available for your notification in REACH-IT before you start the dossier update. When updating a NONS registration, the following three scenarios have to be taken into account:

  • Tonnage band update
  • Update to become the lead or a member of a joint submission
  • Other updates

For more details please continue to Annex 4 of the "How to prepare registration and PPORD dossier" manual at: http://echa.europa.eu/manuals/.

What will happen after I submit my NONS dossier?

Your dossier will undergo a series of initial administrative checks called "business rules". A dossier is accepted for processing by ECHA only if all of the relevant business rules are satisfied. Once your dossier has been accepted for processing:

  • Your dossier will be allocated a submission number.
  • Your dossier will undergo a completeness check.
  • You will receive an invoice, if applicable, for an appropriate fee (for tonnage band upgrades and chargeable confidentiality claims not made under Directive 67/548/EEC).
  • Your dossier will be regarded as complete once ECHA has verified the completeness of the information you submitted and received the payment of the relevant fee in accordance with Article 20(2) of the REACH Regulation.
In the case of an update of a registration in accordance with Article 135 of the REACH Regulation, the submitted information will be evaluated by ECHA pursuant to Article 42 or by the requesting MSCA pursuant to Article 48, depending on the legal basis of the original request of the MSCA under Directive 67/548/EEC.

Will ECHA publish information from my NONS dossier on the website?

Yes. REACH requires that certain information on chemical substances, which is kept in ECHA's databases, is made available to the public, free of charge, over the internet. This concerns, in particular, information specified in Article 119 of REACH. ECHA is already providing public access via the internet to such information from registration dossiers on its website at:http://echa.europa.eu/information-on-chemicals/registered-substances.

Information from NONS notifications will be released in a stepwise approach in order to allow NONS registrants to adapt the content of their dossiers to the REACH format, and insert adequate confidentiality claims if required. NONS registrants who have claimed their notification are being individually informed of the timelines for publication and the actions they need to take in relation to their dossier via a message in REACH-IT.

Please refer to chapter 2.5 of "Dissemination and confidentiality under the REACH Regulation" manual at: http://echa.europa.eu/manuals.

I notified as a Sole Representative under Directive 67/548/EEC and I will take up the duties of the Only Representative under REACH, what are the next steps?

Any Sole Representative agreements are invalid after 31st May 2008. Where the intention is to appoint an Only Representative under REACH, new documentation/contract from the non-Community manufacturer(s) you represent needs to be drawn up.

The company claiming the registration number must indicate in REACH-IT that he/she is entitled to act as the Only Representative.

Please note that Only Representatives have to sign-up in REACH-IT for each and every non-Community manufacturer they represent for the same notification and submit a claim for NONS using the appropriate accounts.

Once you have indicated the notification specifics in the ‘Claim notification module' follow the wizard and:

  • Declare that you have the agreement and the consent of the non-Community manufacturer to become the Only Representative under the REACH Regulation and that you are entitled to claim the registration number (tick the relevant box).
  • Specify the non-Community manufacturer that you will represent as Only Representative for the notified substance.
  • Attach the following documentation from the non-Community manufacturer you represent:
  • Individual letter(s)/contract(s) from the non-Community manufacturer declaring that you are entitled to become their Only Representative under the REACH Regulation for the notified substance. The letter(s) should be in PDF format and written in one of the official Community languages.

 

If all the information specified is correct and matches with that in the notification:

You will instantly receive a submission number, and a reference number for the non-Community manufacturer you represent via REACH-IT.

You can request for the notification to be migrated in IUCLID 6 format from your relevant Member State Competent Authority. You can find their contacts at: http://echa.europa.eu/contacts-of-the-member-state-competent-authorities .

If the information specified does not match with that in the notification, ECHA will not be able to allocate any registration number to you.

You are advised to contact your relevant Member State Competent Authority to resolve the situation (http://echa.europa.eu/contacts-of-the-member-state-competent-authorities).

I notified as a Sole Representative AND as a Domestic Manufacturer AND/OR Importer under Directive 67/548/EEC, what are the next steps?

Once you have indicated the notification specifics in the ‘Claim notification module':

You must first sign-up in REACH-IT for each type of claimant you are (role) for the notified substance in question under Directive 67/548/EEC and submit a claim for NONS using the appropriate REACH-IT account.

In addition, as a former Sole Representative you have to sign-up in REACH-IT for each non-Community manufacturer you represent and submit a claim for NONS using the appropriate accounts.

You should then first request your registration number as a domestic Manufacturer AND/OR Importer (see Q&A 683).

Then you should request your registration number as a Sole Representative (see the process described before).

Generale

What is REACH and where do I find more information about it?

REACH stands for the Regulation for Registration, Evaluation, Authorisation and Restriction of Chemicals. The REACH Regulation entered into force on 1 June 2007 to streamline and improve the former legislative framework for chemicals of the European Union (EU). REACH also created the European Chemicals Agency (ECHA) which has a central co-ordination and implementation role in the overall process. ECHA is located in Helsinki, Finland and manages the registration, evaluation, authorisation and restriction processes for chemical substances to ensure consistency across the countries in which REACH applies.

The following sources of information about REACH are available:

Who is responsible for the enforcement of REACH?

Member States endorse national provisions defining controls and sanctions for non-compliance with REACH. We recommend you to contact the relevant enforcement authorities in your country for information on the national control procedures in place. You can also contact the customs authorities and the national helpdesk for further information:
https://echa.europa.eu/regulations/enforcement
http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-national-helpdesks 

 

Who should I contact if I have a question on REACH?

The first points of contact on REACH are the national REACH helpdesks established in each country of the European Economic Area (EEA). They provide services in their local language(s) and know the national conditions (e.g. national legislation, enforcement authorities, etc.). : http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-national-helpdesks

Trade associations, sector groups, chambers of commerce and other organisations, which are particularly familiar with sector-specific terminology, have set up stakeholder helpdesks to provide tailor-made support for their industrial sectors and products; e.g. plastics, minerals, mineral oils, paints.

ECHA provides assistance particularly to those companies that are registering substances and who have questions on e.g. REACH provisions, ECHA's IT systems and the administration of submitted dossiers.

For non-EU companies we have collected REACH information particularly concerning them, available at: http://echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries. If the questions are related to the conditions in a particular country, you may also turn to the corresponding national REACH helpdesk (see the link above) before contacting ECHA.

Identificazione della sostanza

A. Domande di natura generale

Perché sono tenuto a fornire informazioni analitiche per la mia sostanza?

Queste informazioni sono necessarie per verificare la composizione della sostanza e per garantire che gli identificatori chimici, come la denominazione IUPAC oppure il numero CAS, siano appropriati. 

Quali dati spettrali sono richiesti dall’ECHA?

L’ECHA richiede, come minimo, gli spettri per raggi ultravioletti (UV), raggi infrarossi (IR) e risonanza magnetica nucleare (NMR) (allegato VI, sezione 2.3.5, REACH). Si può anche fornire uno spettro di massa in sostituzione dello spettro della risonanza magnetica nucleare. Per alcune sostanze queste informazioni non sono sufficienti o adeguate; pertanto, in questa eventualità è necessario fornire altri tipi di dati spettrali. Ad esempio, nel caso delle sostanze inorganiche, è probabile che una diffrazione dei raggi X (XRD), una fluorescenza ai raggi X (XRF) o una spettroscopia di assorbimento atomico (AAS) siano tecniche più appropriate.

È possibile avere accesso alle informazioni analitiche di altri (potenziali) dichiaranti?

No,  l’ECHA protegge la riservatezza delle informazioni analitiche presentate dai (potenziali) dichiaranti. 

Che tipo di giustificazione è accettabile per la mancata presentazione di alcuni dati analitici?

Per essere accettabile, una giustificazione si deve basare sulla fattibilità tecnica o la necessità scientifica, ossia si deve fondare su valide argomentazioni scientifiche. 

Si deve considerare il 100 % della composizione della sostanza?

Sì, la somma delle concentrazioni tipiche di ogni componente deve essere pari al 100 %.

Dove posso trovare ulteriori informazioni che mi aiutino a soddisfare i requisiti relativi all’identificazione delle sostanze?

Al momento della preparazione del fascicolo da presentare all’ECHA, raccomandiamo di leggere anche i seguenti documenti:

B. Domande specifiche

In una soluzione tra un agente complessante e un sale metallico si forma un complesso metallico. Tale complesso rimane in soluzione e non è mai isolato. Questo complesso è soggetto all’obbligo di registrazione?

Sì, le sostanze ioniche in soluzione acquosa sono esentate dalla registrazione solo se:

  1. tutte le sostanze iniziali (sali, acidi e basi) della soluzione acquosa sono registrate;
  2. nessuno dei sali nella soluzione acquosa è isolato dalla soluzione; e
  3. i sali rimangono nella loro forma ionica nella soluzione.

In questo caso particolare, la terza condizione non è soddisfatta, poiché i sali non rimangono nella loro forma ionica nel complesso. Pertanto, l’esenzione non si applica e il complesso è soggetto a registrazione. Questo caso è discusso nell’allegato 1 "Miscele ioniche" (Ionic Mixtures) del documento orientativo all’allegato V.
I complessi costituiti da ioni chelati devono essere registrati se essi stessi vengono fabbricati, importati o immessi sul mercato. Tuttavia, nell’allegato V sono indicate diverse esenzioni che possono essere prese in considerazione, ad esempio se il complesso risulta da un agente chelante che agisce come previsto ("sostanze che non sono esse stesse fabbricate, importate o immesse sul mercato e che risultano da una reazione chimica che ha luogo quando agiscono nel modo previsto come: (a) un [...] agente chelante [...]").

La sostanza priva di acqua (anidra) e gli idrati di tale sostanza devono essere considerati essere la stessa sostanza?

Ai fini della registrazione, gli idrati di una sostanza e la sostanza anidra sono considerati essere uguali. Se la sostanza anidra viene registrata dal produttore/importatore e se un’azienda utilizza tale sostanza per produrre la sostanza idratata, tale azienda è considerata utilizzatore a valle. Pertanto, il relativo fascicolo di registrazione deve contenere le informazioni necessarie per la sostanza anidra e la sostanza idratata presenti all’interno della catena di approvvigionamento, vale a dire la valutazione della sicurezza chimica con valutazioni dell’esposizione e caratterizzazioni del rischio delle sostanze idratate e della sostanza priva di acqua. Queste informazioni devono essere comunicate lungo tutta la catena di approvvigionamento nelle schede di dati di sicurezza che devono includere tutti gli elementi fattuali necessari, ad esempio gli scenari di esposizione e gli usi identificati per la sostanza priva di acqua e per la sostanza idratata presenti all’interno della catena di approvvigionamento. Il numero di registrazione della sostanza anidra registrata deve essere specificato nella sezione 1 della scheda di dati di sicurezza. Le disposizioni stabilite per gli utilizzatori a valle ai sensi degli articoli 37 e 38 possono essere attuate tanto per gli idrati di una sostanza quanto per la sostanza anidra.

Nella loro valutazione della sicurezza chimica (CSA) i dichiaranti devono tenere conto delle potenziali implicazioni di forme specifiche della sostanza sugli usi a valle, in particolare quando la forma viene modificata durante l’uso a valle.

Se la mia sostanza contiene una parte anionica e cationica, devo fornire dati analitici per l’identificazione di ogni ione?

Sì,  al fine di confermare la presenza degli ioni, è necessario fornire i dati analitici per l’identificazione e la quantificazione di ogni ione. 

La mia sostanza comprende isomeri configurazionali. Devo considerarla come una sostanza mono-componente?

Gli isomeri configurazionali (ad esempio gli enantiomeri, diastereoisomeri, regioisomeri) sono considerati componenti differenti. Per questa ragione la sostanza potrà essere considerata mono-componente esclusivamente se è presente una sola forma isomerica specifica a una concentrazione minima dell’80 %.

La mia sostanza è una sostanza multi-componente costituita da una massa di reazione di tutte le forme stereoisomeriche possibili per la mia sostanza. Sono tecnicamente tenuto a denominare la mia sostanza come "massa di reazione"?

A condizione che la sostanza ben definita in questione abbia come componenti principali tutte le sue possibili forme stereoisomeriche, questa potrà essere identificata nella sezione 1.1 di IUCLID utilizzando esclusivamente la sua denominazione IUPAC, senza necessità di specificarne la stereochimica. Tuttavia si deve comunque procedere a identificare la sostanza come una sostanza multi-componente. Informazioni sull’identità e sulla concentrazione di ciascuno dei singoli stereoisomeri devono essere riportate nella sezione 1.2 di IUCLID.

C. Come riportare in IUCLID l'identificazione delle sostanze

Come posso specificare le impurezze sconosciute in IUCLID?

Quando la sostanza contiene impurezze che l’interessato non è in grado di identificare, occorre creare in IUCLID una sostanza di riferimento generica. Nella sostanza di riferimento è necessario precisare quanto segue:

  • "impurezze sconosciute" nel campo della denominazione IUPAC; e
  • il numero e il singolo intervallo di concentrazione di ogni impurezza sconosciuta nel campo delle osservazioni.

Inoltre, si devono fornire la concentrazione tipica e l’intervallo di concentrazione delle impurezze sconosciute.
Un esempio illustrativo su come segnalare le impurezze sconosciute in IUCLID è riportato nella sezione 9.4.2 del manuale "Come preparare i fascicoli PPORD e di registrazione", disponibile all’indirizzo: http://echa.europa.eu/manuals.

Devo segnalare gli intervalli di concentrazione per ciascun componente?

Sì, è necessario segnalare gli intervalli di concentrazione (cioè entrambi i valori, minimo e massimo) per ogni componente. Tali valori devono essere rappresentativi della sostanza così come prodotta/importata e possono essere tratti, ad esempio, dai limiti delle specifiche certificate che fanno spesso parte di un certificato di analisi. È importante che gli intervalli di concentrazione siano realistici e non abbiano per oggetto sostanze diverse. 

Cosa accade se non attribuisco una voce CE alla mia sostanza soggetta a regime transitorio?

Una volta che la registrazione ha superato la fase di verifica delle business rules, lo strumento REACH-IT fornirà un numero di elenco. Sarà possibile scaricare da REACH-IT questa voce CE creata automaticamente, nel formato file i5z. Ogniqualvolta si presenti un aggiornamento della propria registrazione sarà necessario attribuire questo numero di elenco.

La mia sostanza è una sostanza UVCB per la quale on riesco a derivare alcuna denominazione IUPAC. Cosa devo riportare nel campo "denominazione IUPAC" (IUPAC name) della sezione 1.1 di IUCLID?

Nel campo "denominazione IUPAC" della sezione 1.1 di IUCLID si deve riportare la denominazione chimica della sostanza UVCB. Le convenzioni per la denominazione da utilizzare per derivare la denominazione chimica delle sostanze UVCB sono riportate nel capitolo 4.3 degli "Orientamenti all’identificazione e alla denominazione delle sostanze in ambito REACH e CLP". Un esempio di denominazione chimica per le sostanze UVCB è "prodotti di reazione di oligomerizzazione di formaldeide e fenolo".

La mia sostanza è una sostanza multi-componente per la quale non riesco a derivare alcuna denominazione IUPAC. Cosa devo riportare nel campo "denominazione IUPAC" (IUPAC name) della sezione 1.1 di IUCLID?

Nel campo "denominazione IUPAC" della sezione 1.1 di IUCLID si deve riportare la denominazione chimica della sostanza multi-componente. Il formato generico per la denominazione chimica è "massa di reazione di" seguita dalle denominazioni di ciascun componente principale separate da "e". In linea di principio, la denominazione dei componenti principali deve seguire le norme IUPAC. Un esempio di denominazione chimica per sostanze multi-componente è "massa di reazione di etilbenzene e m-xilene e o-xilene".

Dove devo segnalare il rapporto degli isomeri presenti nella mia sostanza?

Di norma si deve segnalare separatamente ogni singolo isomero e i corrispondenti livelli di concentrazione tipica, con limite superiore e inferiore, nella sezione 1.2 di IUCLID.
Come scostamento, si possono segnalare gli isomeri in una voce nella sezione 1.2 di IUCLID. Questo approccio può essere considerato appropriato quando gli isomeri sono presenti come miscela di racemo o quando il numero di isomeri è elevato. In tale situazione, si deve procedere come segue:

  • specificare, nei corrispondenti campi della sezione 1.2 di IUCLID, il livello complessivo di concentrazione tipica, con limite superiore e inferiore, degli isomeri ricompresi nella voce;
  • indicare il corrispondente rapporto degli isomeri nelle "Osservazioni" (Remarks) nel blocco ripetibile per tale voce. Se il rapporto relativo degli isomeri varia, è necessario segnalarlo sotto forma di un intervallo di valori;
  • indicare che isomeri specifici non sono stati riportati separatamente nel campo "Giustificazione per scostamenti" (Justification for deviations).
Devo fornire una descrizione del processo di fabbricazione per l’identificazione della mia sostanza UVCB e, in caso affermativo, con quale livello di dettaglio?

Sì, la descrizione del processo di fabbricazione è uno degli identificatori per le sostanze UVCB. Le informazioni devono essere incluse nel campo "Descrizione della composizione" (Description of composition) della sezione 1.2 di IUCLID. Solitamente la descrizione è costituita dalle seguenti informazioni:

  • identità e rapporto dei materiali iniziali;
  • descrizione delle fasi di fabbricazione pertinenti nell’ordine in cui si verificano;
  • parametri operativi pertinenti applicati per controllare la composizione (ad esempio temperatura, pressione, solvente, tipo di catalisi ...);
  • dettagli sulle fasi di estrazione/isolamento/purificazione, ove opportuno.

Inoltre, è anche possibile segnalare gli schemi di reazione o i flussi di lavoro dei processi per completare la descrizione del processo di fabbricazione come allegato al titolo "Descrizione allegata" (Attached description) della sezione 1.2 di IUCLID.

La mia sostanza è un componente di una miscela. Posso riportare la composizione della miscela come "Composizione della sostanza del soggetto giuridico" (Legal entity composition of the substance) nella sezione 1.2 di IUCLID?

No, il campo "Composizione della sostanza del soggetto giuridico" va utilizzato esclusivamente per segnalare composizioni della sostanza in quanto tale che il dichiarante produce o importa. Ad esempio, se la sostanza è formulata con un solvente durante la fabbricazione, si deve segnalare solo la composizione della sostanza senza il solvente come "Composizione della sostanza del soggetto giuridico".

Se la sostanza viene fornita esclusivamente come componente di una miscela, la "Composizione della sostanza del soggetto giuridico" da segnalare è comunque quella per la sostanza in quanto tale.

Non si deve confondere una miscela con una sostanza multi-componente o una sostanza UVCB. Ai sensi dei regolamenti REACH e CLP, una miscela si ottiene mescolando due o più sostanze senza una reazione chimica. Le sostanze di una miscela devono essere registrate separatamente. Di norma, una sostanza multi-componente o una sostanza UVCB è il risultato di una reazione chimica. Una sostanza multi-componente o una sostanza UVCB deve essere registrata come tale.

Voglio avvalermi della disposizione specifica di cui all’allegato V, paragrafo 6, del regolamento REACH, concernente la registrazione degli idrati. Come devo riportare le differenti composizioni rientranti nella registrazione?

Si deve procedere come segue:

  • assegnare la sostanza di riferimento per la sostanza anidra e selezionare il tipo corrispondente di sostanza (mono-componente, multi-componente o UVCB) nella sezione 1.1;
  • per ragioni tecniche, nella sezione 1.2 è necessario indicare la composizione della sostanza anidra come la prima composizione con il tipo "Composizione della sostanza del soggetto giuridico" (Legal entity composition of the substance);
    • chi fabbrica o importa la sostanza anidra è tenuto a segnalarne la composizione come prima composizione;
    • anche quando non fabbrica o importa la sostanza anidra, nella sezione 1.2 il dichiarante è comunque tenuto a segnalare una composizione corrispondente alla sostanza anidra come prima composizione. In questo caso, si raccomanda di indicare una composizione teorica in cui la sostanza di riferimento per la sostanza anidra è segnalata a una concentrazione tipica del 100 % (p/p). Selezionare "Composizione della sostanza del soggetto giuridico" (Legal entity composition of the substance) come "Tipo di composizione" (Type of composition). Nel campo "Descrizione della composizione" (Description of composition), indicare che la composizione riportata è teorica. Nel campo "Giustificazione per scostamenti" (Justification for deviations), indicare quanto segue: "La presente composizione non è né fabbricata né importata. Viene segnalata per pure ragioni tecniche poiché si applica la deroga per la registrazione degli idrati";
  • indicare tutte le altre composizioni pertinenti, compresi i differenti idrati rientranti nella registrazione. Per le composizioni che si riferiscono a idrati, indicare "Idrato rientrante nella registrazione della sostanza anidra" (Hydrate covered by the registration of the anhydrous substance) nel campo "Giustificazione per scostamenti" (Justification for deviations). Il "Tipo di composizione" (Type of composition) delle composizioni idrate riportate deve essere "Composizione della sostanza del soggetto giuridico" (Legal entity composition of the substance).

 

In qualità di importatore di polimeri, quali informazioni analitiche devo riportare nella sezione 1.4 di IUCLID della mia registrazione per il monomero?

Si devono fornire informazioni analitiche sufficienti per verificare l’identità del monomero oggetto della registrazione. Solitamente le analisi constano di dati spettrali e cromatografici e di un cromatogramma del monomero originale o di qualsiasi altra sostanza utilizzata nella fabbricazione del polimero. Per maggiori informazioni, si prega di consultare la Q&A 72 concordata con gli helpdesk nazionali.

Ho difficoltà ad avere accesso ai dati analitici relativi al monomero detenuti dal fabbricante/fornitore non-SEE del polimero. Si tratta di una valida giustificazione per non allegare i dati analitici nella sezione 1.4 di IUCLID?

No, nella sezione 1.4 di IUCLID si devono fornire informazioni sufficienti per identificare il monomero da registrare.
Se si incontrano difficoltà ad accedere alle informazioni detenute dal fabbricante/fornitore non-SEE del polimero, si può prendere in considerazione una delle seguenti opzioni:

  • proporre al fabbricante non-SEE del polimero di nominare un rappresentante esclusivo ai sensi dell’articolo 8 del regolamento REACH;
  • identificare il fabbricante non-SEE del monomero e richiedere direttamente le informazioni analitiche;
  • qualora sia già stato nominato un rappresentante esclusivo dal fabbricante non-UE, proporre a tale rappresentante esclusivo di assumersi la responsabilità legale di cui all’articolo 8 del regolamento REACH per gli importatori dei polimeri (cfr. anche Q&A 834).

Si può anche prendere in considerazione qualsiasi metodo scientifico pertinente per adempiere tale obbligo di informazione. Nel caso in cui si considerino informazioni che non si limitano ai dati analitici sul monomero originario, si consiglia di seguire un approccio chiaro e trasparente, accuratamente documentato, nel riportare le informazioni nella sezione 1.4 della registrazione in IUCLID.

Can the chemical name of a UVCB substance be sufficient to describe the manufacturing process required for its identification?

No. The chemical name alone does not include all the process circumstances determining the composition of the UVCB substance and therefore its identity. For further details on the information expected to be reported on the manufacturing process of UVCB substances, please consult the Q&A 1199.

I encounter difficulties getting hold of the full details of the manufacturing process for the UVCB substance I intend to import. How shall I proceed?

You first need to define which information on the manufacturing process is relevant for the identification of the UVCB substance. The Q&A 1199 will assist you in deciding which information on the manufacturing process matters for the identification of your UVCB substance.

The more you know about the composition of the UVCB substance, the less you will be dependent on the manufacturing process to identify your substance. For instance, you may not need to specify the ratio of reactants used to manufacture the substance if you can define the reaction yield and the content of residual starting materials from the compositional information. Be aware that in this case you will still need to explain why some elements of the manufacturing process expected to be submitted are not provided, as indicated in Q&A 1318.

If the missing information on the manufacturing process prevents you from identifying the substance and the non-EEA manufacturer does not share this information directly with you, you may propose to the non-EEA manufacturer of the UVCB substance that they appoint an only representative (OR) in accordance with Article 8 of the REACH Regulation.

ECHA has also prepared a template that can be used to collect the necessary information from the non-EEA manufacturer. The template is available through our website here.

 

I consider that part of the information expected to be reported on the manufacturing process description according to Q&A 1199 (e.g. ratio of reactants, purification steps, isolation) are not necessary for the identification of my UVCB substance because it is identified and named based on the exact identity of its constituents only. How should I report this in IUCLID?

You need to provide all the relevant information on the manufacturing process in IUCLID section 1.2 as instructed in the Q&A 1199. If you consider that some of the information is not relevant, you need to clearly explain why this information is not included in the same field where the manufacturing process description is provided (i.e. in the ‘Description’ field of IUCLID Section 1.2).

For the identification of a UVCB substance, I am supposed to provide information on the manufacturing process. Can I instead report in IUCLID what I know about the composition of the UVCB substance?

No. The manufacturing process description is necessary to circumvent the limitations of identifying UVCB substances by their composition only. You therefore need to provide both types of information (composition and manufacturing process description) in IUCLID section 1.2. For further information on how to report the manufacturing process description and the composition of UVCB substance, please refer the Q&A 1199 and chapter 9.4.2 of the manual ‘How to prepare registration and PPORD dossiers’ available on the ECHA website: https://echa.europa.eu/manuals.

 

Some of the information on the manufacturing process description I need to include for the identification of my UVCB substance is confidential. Will this information be disseminated?

No. ECHA will not disseminate the manufacturing process description reported by registrants in compositions of the type ’legal entity composition of the substance’ in IUCLID section 1.2.  This concerns both the information reported in the field ‘Description’ and any document included as ‘Attached description’.

Lead registrants need to additionally provide generic information on the manufacturing process of the jointly registered UVCB substance in the section 1.2 field ‘Description’ in compositions of the type ‘boundary composition of the substance’. This information will be displayed on the REACH-IT Joint submission page for the members of that joint submission to see.

What is the substance type of an inorganic substance with variable stoichiometry and how should this variability be reported in the IUCLID dossier?

The substance is in principle identified as an inorganic UVCB due to the variability of the molecular formula. 

The variability in the stoichiometry should be reported under the molecular formula field (e.g. MxGyO2, x=a-b, y=c-d).

In case only one constituent block is reported in section 1.2 of the IUCLID dossier, a justification for reporting a single constituent in the composition of a UVCB substance (expected to have a variable complex composition) should be provided in the “justification for deviations” field.

One example of a valid justification would be:

The substance is a UVCB due to variations at the elemental level and these variations cannot therefore be represented by reporting different constituents but only in the form of a variable molecular formula.

 

Importazione di sostanze nell’UE

To which territories does REACH apply?

REACH is a EU Regulation that directly applies in all Member States of the European Union. REACH is of EEA (European Economic Area) relevance as it has been incorporated into the Agreement on the European Economic Area. This means that REACH also applies in Iceland, Liechtenstein and Norway. Substances imported into the EEA from Switzerland (a non-EU country belonging to the European Free Trade Association but not to the EEA) are treated under REACH in the same way as substances imported from any other non-EEA country. The Member States are best placed to explain how REACH applies to their territories (autonomic areas or overseas territories). We therefore recommend contacting the national REACH helpdesk of the relevant country to clarify specific questions in this regard.

What are the obligations of non-EEA companies?

Manufacturers established outside of the European Economic Area (EEA)/EU do not have direct obligations under REACH, as the EU importer needs to comply with the obligations.  Non-EU companies exporting substances to the EU can (but are not obliged to) appoint an "only representative" to fulfil the obligations of importers. More guidance on only representatives can be found at:
http://www.echa.europa.eu/qa-display/-/qadisplay/5s1R/view/reach/Only+Representative+of+non-EU+manufacturer

and in section 2.1.2.5- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration available at:
http://www.echa.europa.eu/guidance-documents/guidance-on-reach

For further information, see also the webpage concerning the non-EU companies: http://echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries

 

Should the importer always be considered as the same legal entity as the consignee stated on the simplified administrative document (SAD) used by the customs authorities? Does this imply that the consignee is considered to be responsible for registration?

No. The importer is the natural or legal person established within the European Union (EU, for REACH and CLP also covering the European Economic Area, EEA) who is responsible for import, i.e. the physical introduction (of goods) into the customs territory of the EU (Article 3(10) of REACH).

The responsibility for import depends on many factors such as who orders, who pays, and who deals with the customs formalities or the "INCOTERMS" chosen, but these might not be conclusive on their own. In many instances, the end receiver of the goods (the consignee) will also be the legal entity responsible for the import. However, this is not always the case.

If, for example, you order goods from a company (Company B) established in the EU, which acts as a distributor, you probably do not know where the goods originate from. Company B may choose to order the goods from either an EU-based manufacturer or from a non-EU-based manufacturer.

If the Company B chooses to order from a non-EU-based manufacturer, the goods may be delivered directly from them to you to save on transportation costs. If this happens, your company will be stated as the consignee on the simplified administrative document form and customs handling will take place in your country. Payment for the goods will, however, be settled between you and Company B.

Company B should be considered the legal entity responsible for the physical introduction of the goods into the customs territory of the EEA (importer). You would then be a downstream user. The obligation to register would consequently lie with Company B.

You, on the other hand, will have to be able to prove through documentation to the enforcement authorities that you are a downstream user, for example, by showing that the order was placed to the distributor.

In addition, when interpreting the term "importer" according to the REACH Regulation, it is not possible to fall back upon the Community Customs Code (Regulation (EEC) No. 2913/92), recast in Regulation (EU) 952/2013.

What are the obligations of importers of articles?

Under some circumstances, article importers have to register or notify substances in articles to ECHA (see Article 7 of REACH): these obligations are in general the same as for producers of articles. When placing articles on the market in the EEA, importers of articles may also have to communicate information on substances in their articles to their customers. In order to establish whether registration, notification or communication duties apply, any importer of articles is advised to follow first the Guidance in a Nutshell on requirements for substances in articles: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/guidance-in-a-nutshell.

Who is an importer?

An importer is any natural or legal person established within the Community who is responsible for import (Article 3(11) of the REACH Regulation). Import means the physical introduction into the customs territory of the Community (Article 3(10)).

The scope of the customs territory of the Community is defined in the relevant Community legislation on customs that should be consulted for further information. [Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code].

It is important to note, however, that the REACH Regulation and the Customs legislation are independent from each other.

Please note that according to Article 3(12) of REACH, the import of a substance on its own, in mixtures or in articles manufactured or produced outside the European Union is considered to fulfil the conditions for placing the substance, mixture or article on the Union market.

As stated in Section 1.5.3.3 of the Guidance on Registration, the responsibility for import depends on many factors such as who orders, who pays, who is dealing with the customs formalities, but this might not be conclusive on its own. This Guidance can be found on the ECHA website at: http://echa.europa.eu/support/guidance.

Notifiche di sostanze contenute in articoli

A. Domande di natura generale

Where can I find the Candidate List?

The Candidate List and additional useful information is published on ECHA's website at:

http://echa.europa.eu/candidate-list-table
 

What is the Candidate List?

Substances fulfilling one or more of the criteria specified in Article 57 of the REACH Regulation can be identified as "substances of very high concern" (SVHC) and put on the "Candidate List". These SVHC can be:

  • substances meeting the criteria for classification as carcinogenic, mutagenic or reprotoxic (CMR) category 1 A or 1B (in accordance with section 3.6 of Annex I to Regulation (EC) No 1272/2008)
  • persistent, bioaccumulative and toxic (PBT) substances or very persistent and very bioaccumulative (vPvB) substances (according to the criteria of Annex XIII of the REACH Regulation)
  • substances identified on a case-by-case basis for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern (Article 57(f) of REACH Regulation), e.g. endocrine disruptors

The Candidate List is available on the website of ECHA. It has been established according to the procedure described in Article 59 of the REACH Regulation (SVHC identification).

How is the Candidate List updated?

The Candidate List is updated when substances are identified as Substances of Very High Concern. This is normally done twice per year (in June and December). To allow interested parties to be aware of substances which might be included in the Candidate List, a Registry of Intentions is published on the website of ECHA. As a producer, importer or supplier of articles, you are advised to regularly check the Registry of Intentions. This can help you to prepare for possible obligations that could arise when a substance is included in the Candidate List: https://echa.europa.eu/candidate-list-obligations.

You can find further information at: https://echa.europa.eu/substances-of-very-high-concern-identification-explained

What is an article?

Article 3(3) of the REACH Regulation defines an article as "an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition". Chapter 2 of the Guidance on requirements for substances in articles provides information on how to determine if an object fulfils the above definition, including instructions on how to address borderline cases (Appendices 3 and 4).

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

Is packaging considered an article?

Packaging is considered a separate article under REACH. Please refer to section 2.5 of the Guidance on requirements for substance in articles for more information.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

Is there any fee for a substance in articles notification?

There is no fee charged for the notification.

I have stopped production/import of the article containing the Candidate List substance. Do I have to notify and communicate information down the supply chain and to consumers upon request?

If the production/import ended before the substance was included in the Candidate List or before the notification obligation starts to apply (i.e. 6 months after a substance has been included in the Candidate List or 1 June 2011 for substances placed on the Candidate List before 1 December 2010) then you do not have to notify. Please note, however, that for the information requirements specified in Article 33 of the REACH Regulation, the date of supply of the article is the relevant date, i.e. these obligations also apply to producers and importers at the moment when they supply articles which were produced or imported before the substance was included in the Candidate List and are supplied after the inclusion. Please refer to section 3.2.1 of the Guidance on requirements for substances in articles for additional information.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

Regarding the notification obligation, do I have to take into account the tonnage of the substance in articles produced/imported before the substance was put in the Candidate List?

Once a substance enters the Candidate List you have to determine if you have the obligation to notify. One of the inputs needed to determine this is the tonnage of the substance in imported/produced articles per calendar year (or the average of the three previous years if the article has been imported/produced during three years before the start of the notification obligation). In this calculation, you have to include the tonnage in articles imported/produced for the full calendar year, i.e. if applicable, also before the date of the inclusion of the substance in the Candidate List. However, if the three year average is not available, the notifier will need to rely on the amounts of the previous calendar year.

Do I need to notify Candidate List substances in articles made from recycled material?

The notification obligation also applies to producers or importers of articles containing recycled material. If you are a producer or importer, you must assess whether the articles you produce or import fall under the criteria of Article 7(2). It may be difficult to know the exact concentration of a Candidate List substance in, for example, recovered polymers where the concentration varies between each batch.

If your company concludes that the articles contain less than 0.1% of the Candidate List substance, we recommend you to document your basis for this conclusion in case of enforcement.

Can I appoint an only representative (OR) to submit a substance in articles notification?

Yes. A non-EU producer of articles may appoint an Only Representative (OR) to submit a substance in articles notification.

The role and obligations of an Only Representative (OR) are explained in detail in chapter 2 of the Guidance on registration.

The Guidance on registration is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

 

What use will be made of the substance in article notifications? Will they trigger new registration requirements?

The notifications will not trigger a request to register the substance in articles, as such. However, the notification information can be used in addition to several other sources (e.g. registration information) to support identification of further needs for risk management.

If there are grounds for suspecting that the substance is released from the articles under normal or reasonably foreseeable conditions of use and such a release presents a risk to human health or the environment, you may be required as a producer or importer of articles to submit a registration. These decisions will be taken on a case-by-case basis and are not restricted to Candidate List substances.
 

What are the enforcement activities and the penalties foreseen?

Enforcement of the REACH Regulation, including the communication and notification obligations of Candidate List substances in articles, is in the remit of the authorities of the individual Member States.

You can find the contact details at: http://echa.europa.eu/support/helpdesks/national-helpdesks/list-of-national-helpdesks.

Who should I contact if I have further questions?

You should contact your national REACH helpdesk: http://echa.europa.eu/support/helpdesks/national-helpdesks

If you have questions on technical issues on REACH-IT, the link is available at: http://echa.europa.eu/support/dossier-submission-tools/reach-it and for questions related to IUCLID 6 at: http://iuclid.eu/ or if you are not in the European Economic Area (EEA), you may contact the ECHA Helpdesk: http://echa.europa.eu/contact

If you would like to check your general obligations under the REACH Regulation and how to fulfil them, you should use the Navigator: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations.

For general guidance on the provisions of REACH that apply to substances in articles, you should consult the Guidance on requirements for substances in articles available at: http://echa.europa.eu/guidance-documents/guidance-on-reach.

For guidance on how to submit a notification (Article 7(2) of REACH), you should consult:

 

Derogations

Am I exempted from the notification obligation?

You are exempted from submitting a Candidate List substance in articles notification to ECHA if:

  • you can exclude exposure of humans and the environment to the Candidate List substance in the articles during normal or reasonably foreseeable conditions of use, including disposal. Chapter 3.3.2 of the Guidance on requirements for substances in articles provides detailed information on the exemption based on “exclusion of exposure”  
  • the substance has already been registered for that use. Chapter 3.3.1 of the Guidance on requirements for substances in articles provides advice on how to find out if the substance is already registered for that use

The Guidance on registration is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

If you conclude that you are exempted from notifying, in line with one of the two cases above, we recommend that you carefully document the basis for and the reasoning behind this conclusion. In this way, you will be prepared for any enforcement activities at national level.

Note that it might require more resources and be more difficult to properly assess and document exclusion of exposure or to find out if the substance is already registered for the use, than to prepare and submit a substance in articles notification.

How can I demonstrate that there is no exposure to the Candidate List substance present in my article?

Note that it may require more resources and be more difficult to demonstrate “no exposure” than to prepare and submit a substance in articles notification.

A producer/importer of an article wanting to demonstrate 'exclusion of exposure' has to ensure that the Candidate List substance does not come into contact with humans or the environment during the use, including disposal, of the article. Such a justification needs to show that no exposure to humans or the environment takes place during the article service life and the waste stage. For more information on “exclusion of exposure”-based exemption from notification, see chapter 3.3.2 of the Guidance on requirements for substances in articles at: http://echa.europa.eu/guidance-documents/guidance-on-reach

How do I find out if the substance is already registered for a particular use? Can I use information that is disseminated on the ECHA website?

Note that it might require more resources and be more difficult to find out if the substance is already registered for the use, than to prepare and submit a substance in articles notification.

A substance can be considered as having already been registered for a particular use, if two conditions are fulfilled:

  • the substance in question is the same as the substance already registered; and
  • the use in question is the same as the use described in a registration of this substance, i.e. the registration refers to the use in the article.

In this context, “use” includes the use of the substance in the production of an article and, after being incorporated into the article, the use of the substance in the article during the article’s service life stages, including the waste stage.

For more information, see chapter 3.3.1 of the Guidance on requirements for substances in articles.

ECHA’s dissemination portal for substance information, which can be accessed via the ECHA website: https://echa.europa.eu/information-on-chemicals, contains information on registered substances provided by companies in their registration dossiers. It includes a variety of information on the substances which companies manufacture or import and may include information on the uses of the substance, unless the companies have claimed this information as confidential, including use of the substance in articles. The description of the use available here for all life cycle steps consists mainly of elements of the use descriptor system, as well as use name and in some cases contributing activity names. The information will normally not be sufficient on its own to conclude on the sameness of two uses for the purpose of establishing whether an exemption on the basis of Article 7(6) applies. Therefore, the use in question has to be described more in detail than just by using elements of the use descriptor system. For example, the published information that a substance has been registered for use in the Article Category 'Plastic articles' does not necessarily mean the registration is made to cover all plastic articles and all plastic materials. It could mean that use of the substance in production of some specific plastic articles is covered and described in the registration, while other plastic articles are not covered and assessed. The uses of two very different plastic articles may lead to very different exposures to humans and the environment. If the exposure related to the use of your article is not adequately assessed in a registration dossier, it cannot be considered a registered use.

Please note that there are limited possibilities to include information in section 3.5 of an IUCLID registration dossier, apart from the use descriptors. Section 3.5 of the IUCLID registration dossier may however contain 'free text' information, which is not based on the use descriptor system. Whether such information is sufficient to conclude on the sameness of use has to be examined on a case-by-case basis.

Most producers of articles are also downstream users under the REACH Regulation and as such have certain obligations outlined in Title V of the REACH Regulation. Since most substances on the Candidate List are already registered, producers of articles should already have communicated their use to the registrant for the purpose of registrations. Producers of articles may therefore not have to notify if their communicated uses are covered in the registration dossier.

Importers of articles may not have access to detailed information on registered uses. If you are not certain that your specific use is already registered, you should notify.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

I am using a CMR/PBT/vPvB in articles however this substance is not in the Candidate List. Do I need to notify?

Notification requirements apply only to substances already included in the Candidate List and meeting the criteria in Article 7(2) of the REACH Regulation. Therefore, if a substance is not yet in this list there is no need to notify. However, please note that CMR/PBT/vPvB and substances of equivalent concern that fulfil the criteria of Article 57 of the REACH Regulation can be included in the Candidate List. It is advised to keep track of the use of these substances in your articles and to follow the development of the Candidate List via the Registry of Intentions. By signing up for the ECHA e-News (http://echa.europa.eu/news-and-events/news-alerts) you will be alerted every time the Candidate List (http://echa.europa.eu/candidate-list-table) or Registry of Intentions (http://echa.europa.eu/addressing-chemicals-of-concern/registry-of-intentions) is updated with new substances.

How to determine if the notification obligation applies

How do I calculate the concentration of a Candidate List substance in my article?

One of the conditions that triggers your obligation to notify is when the concentration of the Candidate List substance exceeds 0.1% w/w in the article.

You should calculate the concentration of the substance for each article as produced or imported. This threshold applies to each article of an imported object made up of more than one article, which were joined or assembled together.

For more information and examples, see chapter 3.2.3.1 of the Guidance on requirements for substances in articles.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

How do I calculate the total amount of the Candidate List substance in my articles?

One of the conditions that triggers the obligation for you to notify is when the total amount of the Candidate List substance present in all articles produced and/or imported exceeds one tonne per actor per year.

The articles concerned should contain more than 0.1% w/w of the substance. If an article contains the substance at a concentration below 0.1% w/w, this article does not have to be included in the tonnage calculation.

The calculation of the total amount in tonnes of the same Candidate List substance in all articles produced or imported (either isolated or incorporated in complex objects) by the same actor requires 3 steps:

1. Determination on whether the Candidate List substance in question is present at above the 0.1% w/w concentration threshold for each article produced or imported.

The calculation of the concentration of the Candidate List substances in articles or complex objects is done as described in Table 5 of the Guidance on requirements for substances in articles.

2. Calculate the amount in tonnes of the Candidate List substance in each article or article type produced or imported per year where it is present above the 0.1% w/w concentration threshold.

3. Calculate the total amount in tonnes for all articles by summing up the amounts calculated for each article or article type according to point 2 above.

The one tonne per year limit applies to the total tonnage produced/imported, in the European Economic Area (EEA) by the same legal entity.

If you believe you are close to one of the thresholds but are unsure whether you exceed it or not, we recommend you to notify.

Chapter 3.2.3.2 of the Guidance on requirements for substances in articles provides further explanations, namely on the concept of article type, and examples on how to calculate the tonnage.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

How do I know that a Candidate List substance is present in my article?

Identifying substances in articles, namely Candidate List substances, and quantifying their amounts is in many cases only possible if the respective information is made available by the actors in the supply chain. Supply chain communication is therefore the most important and efficient way of gathering the information needed in order to identify your obligations under REACH. This information can be obtained via, e.g.:

  • Standardised REACH information from suppliers in the EU, e.g. safety data sheets (SDSs)
  • Voluntary information tools to exchange information on articles, e.g. IT systems and tools
  • Requesting information up the supply chain

It is advised that the information received from suppliers is properly evaluated.

The information you need can often be derived from standardised information that is obtained from suppliers of substances/mixtures based in the European Economic Area - EEA (e.g. SDSs or, where a SDS is not required, safety information and regulatory requirements (Article 32 of the REACH)). In the EEA, suppliers of articles containing more than 0.1% w/w of a Candidate List substance must provide available and relevant safety information (Article 33 of the REACH), including, as a minimum, the name of that substance.

Please be aware that the communication obligations arise from the presence of the Candidate List substance in the article. These obligations apply regardless of whether or not the supplier is aware of the presence of the substances. Therefore, it is in the interests of the supplier to seek information on the presence of Candidate List substances. Proactive requests in the supply chain are often useful to obtain the necessary information, in particular when the supplier of the article is outside the EEA.

Chemical analysis, although a possible way to identify and quantify substances in articles, is time consuming, costly and difficult to organise. If other approaches to obtaining information fail or become too complicated, conducting chemical analysis may nevertheless be an option to obtain information on the composition of articles. Chemical analysis may be helpful in certain situations. It can serve to obtain information needed for compliance with REACH and to confirm the information received from suppliers.

For more information, see Chapter 5 and Appendix 5 of the Guidance on requirements for substances in articles:
http://echa.europa.eu/guidance-documents/guidance-on-reach

 

Do I need to notify and communicate information down the supply chain for certain boron substances included in the Candidate List, which are involved in the production of boron glass articles but not present as such in these articles?

The obligation to notify under Art. 7(2) of REACH and to communicate down the supply chain under Art. 33 of REACH only applies to articles which contain Candidate List substances.

Certain boron substances included in the Candidate List, such as diboron trioxide, boric acid and disodium tetraborate, are involved in processes leading to the production of articles containing “borosilicate glass”. In these processes, the boron substances are usually first chemically transformed into a manufactured glass substance. The glass substance is subsequently processed into articles. In these usual cases, the boron substances are completely transformed and are not present as such in the final glass article. Consequently, there is no obligation to notify under Art. 7(2) of REACH, nor to communicate information down the supply chain under Art. 33 of REACH.

Please note that it remains the responsibility of companies to assess for their specific use of the Candidate List boron substances whether these are completely transformed into glass in the manufacture of “borosilicate glass” and whether the Candidate List substance is present in the boron glass articles.

Information Requirements

How can I provide substance identity information when notifying a substance in article?

This information should be provided in your substance in articles notification. As a minimum, it should include the substance name and/or EC and CAS numbers.

You can find information on substance identity in the Candidate List available at: http://echa.europa.eu/candidate-list-table

Substance identity information, namely for group entries, may also be available in the "supporting documentation column" of the same webpage.

If you decide to prepare your notification online in REACH-IT, you only need to select your substance/Candidate List entry by typing the name, EC or CAS number in the correspondent field in the substance identification section of the wizard.

If you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT, to facilitate the submission process, ECHA publishes pre-filled substance datasets with substance identity information in the Candidate List. The manual "How to prepare a substance in articles notification" provides guidance on how to download and use these datasets:
http://echa.europa.eu/manuals

How can I provide information on classification and labelling when notifying a substance in articles?

This information should be provided in your substance in articles notification.

If you decide to prepare your notification online in REACH-IT, the classification is pre-filled automatically by the wizard for your selected Candidate List substance/entry. The classification is pre-filled for your Candidate List substance/entry as follows:

  • If there is a match with an entry of Annex VI to CLP, the harmonised classification is included in your notification.
  • If there is no match with an entry of Annex VI to CLP, the following information is included in your notification: “No harmonised classification according to Annex VI of CLP is available for this Candidate List entry”.
  • If there are two or more matches with the entries of Annex VI to CLP, you need to select one; the selected harmonised classification entry is included in your notification.

If you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT, to facilitate the submission process, ECHA publishes pre-filled substance datasets with classification information in the Candidate List. The manual "How to prepare a substance in articles notification" provides guidance on how to download and use these datasets:
/manuals  

The Candidate List can be found at: /candidate-list-table

 

How can I describe the use of the Candidate List substance in my article?

This information should be provided in your substance in articles notification by using the technical function descriptor, i.e. indicating the function of the Candidate List substance in the article, i.e. the role that the substance fulfils when it is used in the article (what it actually does in your article or in a mixture incorporated in the article).

If you decide to prepare your notification online in REACH-IT, in the Article(s)/Use(s) section of the wizard, you can describe the use(s) of the substance in the article(s) by using the “Technical function of the substance during use” field in each service life record.

If you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT, you can describe the use(s) of the substance in the article(s) by using the "Technical function of the substance during use" field in section 3.5.6 of IUCLID. Chapter 7.3.3.1. of the manual "How to prepare a substance in articles notification" provides guidance on how to fill this IUCLID section.

Further details on the use(s) of the substance in the article(s) can be provided in the free text fields “Further description of use” of the on-line wizard or IUCLID, in the sections mentioned above, or if appropriate, by using other use descriptors (e.g. Process categories - PROC).

The manual "How to prepare a substance in articles notification" is available on the ECHA website at:
https://echa.europa.eu/manuals  

Further information on the use descriptors can be found on the Guidance on Information Requirements and Chemical Safety Assessment - Chapter R.12 on use description available on the ECHA website at: https://echa.europa.eu/documents/10162/13632/information_requirements_r12_en.pdf/ea8fa5a6-6ba1-47f4-9e47-c7216e180197

How can I describe the use of my article?

In your notification you should identify all articles containing the Candidate List substance and provide for each one of them:

  • a description of the article and its different integral parts (e.g. coating);
  • a description where in the article the Candidate List substance is present, and if applicable, a description of the complex object where the article is joined or assembled as a component;
  • if the article is to be used by consumers and/or workers; and
  • a brief description of the use(s) of the article, including disposal.

The brief description of the use of the article during its service life, including disposal, should be provided by using relevant use descriptors as explained in detail in the Chapter R.12 on use description of the Guidance on Information Requirements and Chemical Safety Assessment. For articles the relevant descriptors are the following:

  • Article category (AC) related to service life of articles containing the substance (and waste stage)
  • Environmental release category (ERC)
  • Process category (PROC) for production of articles and their use by workers
  • Technical function (TF) of the substance in the article

You should also provide exposure-related information when describing the use(s) of your articles, including disposal. You may also wish to include information on the substance tonnage present in the article(s) and on the safe and proper use/handling of the article(s), as well as appropriate instructions for its disposal that you communicate under REACH Article 33.

Similar articles with similar uses can be grouped under the same use description.

The description of the use(s) of your article(s) must be provided in each created service life record created in the

  • section Article(s)/Use(s) of the wizard, if you decide to prepare your notification online in REACH-IT, following the instructions in the help text; or
  • section 3.5.6 of IUCLID, if you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT; chapter 7.3.3.1. of the manual "How to prepare a substance in articles notification" provides guidance on how to fill this IUCLID section.

The manual "How to prepare a substance in articles notification", which also includes useful advice and examples for an online notification preparation, is available on the ECHA website at:
https://echa.europa.eu/manuals  

Further information on the use descriptors can be found on the Guidance on Information Requirements and Chemical Safety Assessment - Chapter R.12 on use description available on the ECHA website at: https://echa.europa.eu/documents/10162/13632/information_requirements_r12_en.pdf/ea8fa5a6-6ba1-47f4-9e47-c7216e180197

How can I provide the tonnage range?

This information should be provided in your substance in articles notification. As a minimum requirement, the tonnage range is to be provided.

If you decide to prepare your notification online in REACH-IT, in the section Tonnage, you must report the tonnage band of the substance contained in the articles and if you wish provide the actual estimated quantities. The help text of the wizard provides you guidance on how to fill this section.

If you decide to prepare your notification beforehand in a IUCLID dossier, you are required to report the tonnage band of the substance contained in the articles in the IUCLID Dossier Header, when creating the dossier to be uploaded to REACH-IT. In section 3.2 of IUCLID, you can indicate the tonnage of the Candidate List substance contained in the produced/imported articles. Chapters 7.3.1. and 8 of the manual "How to prepare a substance in articles notification" provides guidance on how to fill these IUCLID sections, including which years to base the calculation on.

You have the possibility to provide the tonnage of substance per article/use if you so wish in each created service life record created in the section Article(s)/Use(s) of the online wizard or in section 3.5.6 of IUCLID.

The manual "How to prepare a substance in articles notification" is available on the ECHA website at:
https://echa.europa.eu/manuals  

See also Q&A 536

When do I have to submit information on my production site? Is it possible to include several sites in the same notification?

Only producers of articles who produce their articles in the European Economic Area (EEA) will have to enter their production sites. Article importers do not need to fill in this information.

If your company has several sites producing articles, you can list all the sites in one notification. Different notifications should not be made for different sites if the sites belong to the same legal entity.

If you decide to prepare your notification online in REACH-IT, please provide information on your production sites in section Role(s) in the supply chain after reporting your role as producer of article by selecting “Manufacturer”. Please refer to the help text of the online wizard for additional information.

If you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT, please refer to chapters 3 and 7.3.2 of the manual "How to prepare a substance in articles notification" for additional information.

The manual "How to prepare a substance in articles notification" is available on the ECHA website at:
https://echa.europa.eu/manuals  

 

What are the pre-filled substance datasets?

This question is not relevant to notifications prepared online in REACH-IT.

To facilitate the submission of substance in articles notifications ECHA has made available pre-filled substance datasets in IUCLID format (i6z files) for substances on the Candidate List. These datasets are only relevant if you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT. They contain information on substance identification, composition and classification and labelling. Each substance has its own pre-filled dataset, which can be downloaded from the Candidate List webpage.

Chapters 5 and 6 of the manual "How to prepare a substance in articles notification" provide information on how to download and use the datasets. This manual is available on the ECHA website at:
https://echa.europa.eu/manuals  

The Candidate List is published on ECHA's website at: http://echa.europa.eu/candidate-list-table

How can I find the registration number?

The registration number only needs to be included in the notification dossier if the substance has already been registered and the registration number is available to the notifier. If the article is imported from outside the EU, this field does not need to be filled. Producers of articles, incorporating the Candidate List substance into the article themselves, should normally have access to the registration number via the Safety Data Sheet (SDS) for the substance. In this case, the article producer is likely to be exempt from the notification obligation however he should verify that his use is indeed covered by the registration (see Q&A 530).

How can I provide the registration number?

If available, the registration number should be provided in your substance in articles notification.

It can be inserted in the

  • section Administrative information of the wizard, if you decide to prepare your notification online in REACH-IT, following the instructions in the help text; or
  • section 1.3 of IUCLID, if you decide to prepare your notification beforehand in a IUCLID dossier and then upload it to REACH-IT; chapter 7.1.3. of the manual "How to prepare a substance in articles notification" provides guidance on how to enter this information in IUCLID. This manual is available on the ECHA website at:
    https://echa.europa.eu/manuals  

 

Which is the "per year" definition for notification purposes?

Article 3(30) of the REACH Regulation specifies that "per year" means "per calendar year", i.e. 1st January – 31st December. However, for the purpose of the tonnage calculation, if the article has been manufactured or imported for at least three consecutive years the average volume of the preceding three years is recommended to be used. However, if the three year average is not available, the notifier will need to rely on the amounts of the previous calendar year.

At which stage of the manufacturing process do I have to notify?

Notification is required from producers or importers of articles, therefore you have to notify only when the object manufactured/imported is an article. Please refer to Chapter 2 of the Guidance on requirements for substances in articles for additional information on the distinction between a substance/mixture and an article. You should also refer to Tables 3 and 4 of the Guidance, in chapter 3.2.2, if you are dealing with coated articles and complex objects.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

Submission of the notification dossier

What is the deadline for notification?

A notification of a substance in articles shall be made at the latest 6 months after the substance has been included on the Candidate List. The obligation started to apply from 1 June 2011.

What are the implications if one fails to submit a notification in time? Can it be done later?

If you have the obligation to notify a substance in your articles and the deadline has already passed, you are encouraged to notify immediately. You might face national enforcement sanctions if you fail to meet the deadline. Although ECHA accepts notifications after the legal deadline, this does not prevent your national enforcement authorities to impose sanctions on you.

What if I start to import the substance in articles after it has been included in the Candidate List?

If the import of the substance in articles starts after the notification deadline has expired (i.e. 6 months after the inclusion in the Candidate List), notifications must be made without undue delay as soon as the conditions related to the notification obligation are met, i.e. as soon as the 1 tonne per year threshold has been reached. 

How many articles can I submit in one notification for the same substance?

One notification should be submitted for all the articles produced or imported containing the same substance by/to one legal entity. You are however requested to indicate the uses for each different type of article in your notification.

If you are producing or importing new articles containing the Candidate List substance above 0.1% w/w, which are not reported in your submitted notification, you must update your notification without undue delay, given that the conditions related to the notification obligation are met.  

Is it possible to submit a single notification for different substances or different importers/manufacturers?

No, it is necessary to submit a separate notification for each substance and for each importer/manufacturer.

Do I have to update my notification?

In order to be able to demonstrate compliance with your obligations, you are recommended to update your notification if the information included in the notification changes. Examples of important changes could be: change in tonnage range.

However, if you are producing or importing new articles containing the Candidate List substance above 0.1% w/w, which are not reported in your submitted notification, you must update your notification without undue delay, given that the conditions related to the notification obligation are met.    

How can I update my notification of substances in articles using the webform?

You cannot update a notification that was submitted with the webform. Instead, a new notification will need to be created from scratch and submitted to ECHA.

If you stop importing or producing articles containing a Candidate list substance, you should inform ECHA directly via REACH-IT using the "Cease manufacture" functionality.

How can I update my notification of substances in articles using REACH-IT and IUCLID?

The update of your notification needs to be initiated from the reference number page in REACH-IT. You can access to this page by log in to your REACH-IT account at https://idp-industry.echa.europa.eu/idp/

At the top of the reference number page in REACH-IT, you can update your notification by clicking on

  • “Create and submit online an update”, if you have prepared your notification online in REACH-IT or you have submitted it via web form (closed since October 2017); To prepare and submit your notification update online, please follow the wizard instructions.
  • “Submit a IUCLID dossier update”, if you have submitted your notification by uploading a IUCLID dossier; After updating your IUCLID dataset and creating your updated notification IUCLID dossier, you can submit the dossier update via REACH-IT, by uploading it; Please follow the submission wizard instructions.

If you stop importing or producing articles containing a Candidate list substance, you should inform ECHA directly via REACH-IT using the "Cease manufacture" functionality in the reference number page.

Please find further guidance on REACH-IT at https://www.echa.europa.eu/support/dossier-submission-tools/reach-it

Polimeri e monomeri

Do I have to register polymers?
According to Article 2(9) of REACH polymers do not have to be registered, but according to Article 6(3) of REACH, the monomer substance(s) and other substances of the polymers that have not already been registered by an actor up the supply chain, are to be registered if both the following conditions are met:
- the polymer consists of 2 % weight by weight (w/w) or more of such monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) (i.e. free or unbound monomers shall not be considered when checking this condition);
 
- the total quantity of such monomer substance(s) or other substance(s) makes up 1 tonne or more per year (the total quantity in this context is the total quantity of monomer or other substance ending up in the final polymer unbound or chemically bound to the polymer)
 
The REACH Regulation defines polymers in Article 3(5) and monomers in Article 3(6) of REACH.
 
The European Commission may according to Article 138(2) of the REACH Regulation present legislative proposals with requirements for the registration of polymers once a practicable and cost-effective way of selecting polymers for registration on the basis of sound technical and valid scientific criteria can be established.
 
Detailed guidance and practical examples are provided in the Guidance for monomers and polymers: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Can I register monomers as intermediates in accordance with Article 17(2) or 18(2) of the REACH Regulation?
According to Article 6 (2) of REACH, the reduced registration provisions with regard to on-site isolated and transported intermediates do not apply to monomers. This means that a full registration dossier must be submitted even if a monomer is used as an intermediate under strictly controlled conditions.
What is an impurity in a polymer?

An impurity in a polymer is defined as an unintended constituent present in the manufactured polymer substance. It may originate from the starting materials, such as the monomers or any other reactants, or be the result of secondary or incomplete reactions during the production process. While it is present in the final substance it was not intentionally added. Examples of impurities in a polymer include unreacted monomers or other reactants, residual polymerisation catalyst, or any contaminant from the manufacturing process. The definition and detailed guidance on how to handle impurities can be found in Section 4.2.- 'Substances of well defined composition', Section 4.3.- 'UVCB substances', and Chapter 5- 'Criteria for checking if substances are the same' of the Guidance for identification and naming of substances Under REACH and CLP: http://echa.europa.eu/guidance-documents/guidance-on-reach

What is an additive in a polymer?
Some substances are commonly added to polymers for the purpose of adjusting or improving their appearance and/or the physicochemical properties of polymeric material.
 
Additives which are necessary to preserve the stability of a polymer must be regarded as a part of the polymer in accordance with Article 3(1) of REACH. Any other unbound "additive" must be regarded as a component of a mixture and not as an additive in accordance with Article 3(1) of REACH.
 
Thus, the importer of a polymer containing additives does not need to register these additives provided that the additives are added to preserve the stability of the polymer. Note however that there is the general obligation to register substances imported in a polymer mixture in quantities of at least 1 tonne per year. Detailed guidance and practical examples are provided in the Guidance for monomers and polymers: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Beside registration requirements, do I have other obligations for polymers under REACH?

The provisions under the REACH Regulation with regard to information in the supply chain (Title IV), authorisation (Title VII), restrictions (Title VIII) and classification and labelling C&L (Title XI) may also apply to polymers. Further information on this issue is provided in Section 3.2.2- 'Application for authorisation', Section 3.2.3- 'Compliance with restrictions', 3.2.4- 'Classification and labelling', and Section 3.2.5- 'Information down the supply chain' of the Guidance for monomers and polymers: http://echa.europa.eu/guidance-documents/guidance-on-reach.

Are there registration obligations for manufacturers and importers of natural polymers that have not been chemically modified?3
Natural polymers are understood as polymers which are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted (i.e. they may or may not fulfil the criteria set out in Article 3(39) of the REACH Regulation).
 
Following Article 2(9) of the REACH Regulation, any polymer meeting the criteria of Article 3(5) of the REACH Regulation does not have to be registered.
 
According to Article 6(3) of the REACH Regulation any manufacturer or importer of a polymer shall submit a registration for the monomer substance(s) or any other substance(s) that meet the criteria mentioned in the respective article. However, monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) in natural polymers can, for practical reasons, be treated as "non-isolated intermediates" and do not have to be registered.
 
3This FAQ has been agreed by the Competent Authorities of the Member States (REACH CA) in October 2008.
Are there registration obligations for manufacturers and importers of natural polymers that have been chemically modified?

Natural polymers are understood as polymers, which are the result of a polymerisation process that has taken place in nature, independently of the extraction process with which they have been extracted (i.e. they may or may not meet the criteria set out in Article 3(39) of the REACH Regulation).

Following Article 2(9) of the REACH Regulation, any polymer meeting the criteria of Article 3(5) of the REACH Regulation does not have to be registered. This includes natural polymers, which are chemically modified (e.g. post-treatment of natural polymers).

Monomer substance(s) or other substance(s) in the form of monomeric units and chemically bound substance(s) originating from the natural polymer can for practical reasons be treated as "non-isolated intermediates" and do not have to be registered. The substances used to chemically modify the natural polymer and which are chemically bound within the final polymer need to be registered according to the REACH requirements.

This FAQ has been agreed by the Competent Authorities of the Member States (REACH CA) in October 2008.

Importers of polymers are obligated to register monomers or other substances chemically bound to the polymers. Do they have to submit spectral data and chromatograms of the original substances used to manufacture the polymers?

Yes. The registration of a monomer or other substance chemically bound to a polymer has to include spectral data and a chromatogram of the original monomer or other substance used to manufacture the polymer.

If it is not technically possible, or if it does not appear scientifically necessary to include this information, the reasons need to be clearly stated. Generic spectral data or a generic chromatogram cannot be accepted as this would not reflect the actual composition of the monomer or other substance used to manufacture the polymer.

It may be the case that a company imports a type of polymer from different sources, and therefore a monomer or other substance used in the manufacture of this polymer probably also stems from different sources. Even when a company imports a polymer from just one source, it can happen that a monomer or other substance used in the manufacture of this polymer stems from different sources.

In these cases, the importer of the polymer is responsible for assessing the sameness of the monomer or other substance from the different sources. If they consider that the substances from the different sources are the same, they have to submit just one registration for this substance with one set of spectral data and one representative chromatogram. In this process, they might still have found out that the substance from the different sources has different impurity profiles. They need to then refer to these different compositions of the substance in their registration dossier.

Are natural proteins and hydrolysed natural proteins polymers as defined in the REACH Regulation?

Natural proteins may be considered as polymers under REACH provided that they have at least 50 weight percent of polymer molecules (in this case, molecules including a sequence of at least four amino acid monomer units) and the content of molecules presenting the same molecular weight remains below 50 weight percent.

Similarly, hydrolysed natural proteins may be considered as polymers if they fulfil the abovementioned criteria. If the degree of hydrolysis is to such an extent that less than 50 percent of the weight of the substance consists of polymer molecules (as defined in chapter 2.2 of the Guidance for monomers and polymers) and/or the amount of polymer molecules presenting the same molecular weight is at least 50 weight percent, the hydrolysed natural protein is not a polymer and, hence, is not covered by the registration exemption for polymers under REACH.

Preregistrazione

Modifiche alla pre-registrazione dopo il 1° dicembre 2008

È possibile trasferire una preregistrazione da un importatore a un rappresentante esclusivo?

No, non è possibile trasferire le preregistrazioni dagli importatori a un rappresentante esclusivo.

Ulteriori informazioni sul principio generale di variazione della persona giuridica sono riportate nel capitolo 1.5.3.1 degli Orientamenti sulla registrazione disponibili all’indirizzo https://echa.europa.eu/it/guidance-documents

Obblighi conseguenti alla pre-registrazione

Quali sono i compiti derivanti dalla preregistrazione?

Per ciascuna sostanza preregistrata è stata predisposta una pagina dedicata al pre-SIEF in REACH-IT, dove trovate i recapiti delle altre imprese che hanno effettuato la preregistrazione usando lo stesso identificatore della sostanza (per esempio il numero EC).

Dovete mettervi in contatto per stabilire chi sarà il dichiarante capofila e verificare se le sostanze sono le stesse.

All’interno del SIEF, procederete a condividere i dati sulla sostanza in vostro possesso con i co-dichiaranti, ripartire i costi e preparare la registrazione collettiva.

L’obiettivo del SIEF è quello di evitare di ripetere le sperimentazioni relative alle sostanze e concordarne la classificazione ed etichettatura. In un SIEF, le aziende devono condividere gli studi basati sulla sperimentazione animale al fine di ridurre tale pratica a un minimo assoluto. Possono inoltre condividere altri dati rilevanti ai fini del REACH. È un’opportunità per generare e ottenere i dati richiesti dal regolamento REACH per la registrazione in un modo economicamente vantaggioso.

Ho una preregistrazione valida. Posso cessare la fabbricazione o l’importazione alla fine della proroga della scadenza di registrazione?

Ai sensi dell’articolo 28 del regolamento REACH, un pre-dichiarante può usufruire delle proroghe delle scadenze di registrazione di cui all’articolo 23. La preregistrazione non stabilisce alcun obbligo di continuare la fabbricazione o l’importazione delle sostanze. Tuttavia, dovreste considerare che gli altri membri del SIEF possono chiedervi di fornire loro le informazioni necessarie ai fini della registrazione e, se siete in possesso di tali informazioni, sarete tenuti a farlo.

Il numero di trasmissione è la prova che la mia sostanza gode dello status di sostanza soggetta a un regime transitorio?

No, non lo è. Né la ricezione del numero di trasmissione, né la ricezione del numero di preregistrazione costituiscono una prova del fatto che la sostanza gode dello status di sostanza soggetta a un regime transitorio.

Per determinare se la vostra è una sostanza soggetta o non soggetta a un regime transitorio, consultate la sezione 1.7.1 degli Orientamenti sulla registrazione, disponibili all’indirizzo http://echa.europa.eu/it/support/guidance.

La preregistrazione di una sostanza soggetta a un regime transitorio senza un numero CE non impone al dichiarante potenziale di presentare, in sede di preregistrazione, prove documentali che dimostrino lo status di sostanza soggetta a un regime transitorio ai sensi dell’articolo 3, paragrafo 20, del regolamento REACH (cfr. articolo 28, paragrafo 1, del regolamento REACH).

Ciononostante, i pre-dichiaranti devono confermare nella preregistrazione che intendono rivendicare lo status di sostanza soggetta a un regime transitorio per la propria sostanza. I fabbricanti/importatori devono tenere queste informazioni sempre a disposizione delle autorità competenti degli Stati membri.

Come posso utilizzare il numero di preregistrazione?

Il numero di preregistrazione è una conferma che la preregistrazione è stata ricevuta dall’ECHA. Spetta a ciascun pre-dichiarante decidere come utilizzare queste informazioni.

Devo indicare il numero di preregistrazione sulle schede di dati di sicurezza (SDS)?

In generale, il regolamento REACH non disciplina l’uso del numero di preregistrazione. Avendo il compito di far rispettare il regolamento REACH, i singoli Stati membri possono prevedere obblighi nazionali in materia di comunicazione del numero di preregistrazione.

In ogni caso, il numero di registrazione (una volta assegnato) deve essere indicato sulla scheda di dati di sicurezza, come previsto al punto 1.1 dell’allegato II del regolamento REACH. Maggiori informazioni sui numeri di registrazione sono riportate nella sezione 7.4 degli Orientamenti sulla registrazione disponibili sul sito web dell’ECHA all’indirizzo http://echa.europa.eu/it/support/guidance

Come verranno utilizzati i dati di preregistrazione?

L’ECHA pubblica l’elenco delle sostanze preregistrate all’indirizzo https://echa.europa.eu/it/information-on-chemicals/pre-registered-substances.

Le informazioni pubblicate comprendono:

  • il numero EINECS e il numero CAS della sostanza (se disponibili) e altri codici di identificazione;
  • la prima scadenza di registrazione prevista;
  • le denominazioni e gli altri identificatori di sostanze correlate di cui i pre-dichiaranti dispongono, ossia quelli per i quali le informazioni disponibili possono essere rilevanti ai fini dell’adeguamento delle prescrizioni sulla sperimentazione utilizzando il metodo «read-across», le (Q)SAR e/o il raggruppamento di sostanze.

L’elenco, così come pubblicato dall’ECHA, non mostra l’identità dei pre-dichiaranti. Di conseguenza, per appurare se una sostanza è stata preregistrata in una particolare catena di approvvigionamento, gli utilizzatori a valle dovrebbero rivolgersi ai propri fornitori o ad altri soggetti più a monte nella propria catena di approvvigionamento.

Questa informazione è visibile anche in REACH-IT a coloro che hanno pre-registrato la stessa sostanza e a coloro che hanno pre-registrato sostanze affini per il «read-across».

Quali sono le sostanze soggette a un regime transitorio?

Le sostanze che soddisfano almeno uno dei seguenti criteri possono essere considerate soggette a un regime transitorio, conformemente all’articolo 3, paragrafo 20, del regolamento REACH:
 

  • sostanze elencate nell’inventario europeo delle sostanze chimiche esistenti a carattere commerciale (EINECS);
  • sostanze fabbricate nell’UE (inclusi i paesi in fase di adesione il 1° gennaio 2007), ma che non sono state immesse sul mercato dell’UE dopo il 1° giugno 1992;
  • sostanze definite «ex polimeri».

Informazioni dettagliate sono disponibili nella sezione 1.7.1.1. Sostanze soggette a un regime transitorio nella Orientamenti sulla

registrazione disponibili all’indirizzo http://echa.europa.eu/web/guest/support/guidance-on-reach-and-clp-implementation.
Quali sono le diverse scadenze di registrazione?

L’articolo 23 del regolamento REACH prevede un regime con diverse scadenze di registrazione per le cosiddette «sostanze soggette a un regime transitorio», a seconda della fascia di tonnellaggio e dei pericoli presentati dalla sostanza.

Le scadenze per presentare un fascicolo di registrazione all’ECHA sono le seguenti:

  • 30 novembre per le sostanze CMR (sostanze classificate come cancerogene, mutagene o tossiche per la riproduzione, categoria 1 o 2, a norma della direttiva 67/548/CEE) ≥ 1 tonnellate/anno, R50/53 (sostanze classificate come altamente tossiche per gli organismi acquatici, che possono provocare effetti negativi a lungo termine per l’ambiente acquatico (R50/53), a norma della direttiva 67/548/CEE) ≥ 100 tonnellate/anno e altre sostanze ≥ 1 000 tonnellate/anno; oppure
  • 31 maggio 2013 per le altre sostanze ≥ 100 tonnellate/anno; oppure
  • 31 maggio 2018 per le altre sostanze ≥ 1 tonnellata/anno.
Come faccio a calcolare il tonnellaggio per determinare la corrispondente scadenza di registrazione?

La quantità effettiva di fabbricazione e/o importazione, i tonnellaggi previsti e il grado di pericolosità della sostanza sono i fattori che determinano la scadenza di registrazione pertinente. La quantità annua prevista deve essere calcolata per anno di calendario.

Orientamenti dettagliati ed esempi pratici sono forniti negli Orientamenti sulla registrazione (sezione 1.6.2. Calcolo del volume da registrare) nonché all’articolo 3, paragrafo 30, del regolamento REACH: http://echa.europa.eu/it/support/guidance

Che cosa sono i numeri di preregistrazione e preregistrazione tardiva?

A ogni sostanza soggetta a un regime transitorio preregistrata (eventualmente con preregistrazione tardiva) con esito positivo è stato assegnato un numero di preregistrazione (tardiva). Questo numero di riferimento è esclusivo per ciascuna azienda e sostanza preregistrata.

La struttura del numero di preregistrazione (tardiva) è la seguente:
<TIPO>-<NUMERO BASE>-<SOMMA DI CONTROLLO>-<NUMERO INDICE>

Esempi:
05 - 1234567890 - 49 - 0000
17 - 1234567890 - 49 - 0000

dove:

  • 05 è il tipo di preregistrazione (presentata prima del 1.12.2008)
  • 17 è il tipo di preregistrazione tardiva (presentata tra il 1.12.2008 e il 31.05.2017)
  • 1234567890 è il numero esclusivo attribuito casualmente, composto da 10 cifre;
  • 49 è la somma di controllo calcolata (numero variabile composto da 2 cifre);
  • 0000 è il numero indice.

I numeri di preregistrazione e preregistrazione tardiva hanno lo stesso formato di altri numeri di riferimento assegnati automaticamente da REACH-IT.

In qualità di utilizzatore a valle posso verificare il numero di preregistrazione online e vedere se il mio fornitore ha preregistrato la sostanza?

No, non c’è una funzionalità in REACH-IT che sia in grado di raccogliere e distribuire queste informazioni in quanto potrebbero essere considerate informazioni commerciali riservate. Gli utilizzatori a valle sono invitati a stipulare adeguati accordi contrattuali con i fornitori al fine di assicurarsi di essere in regola con gli obblighi ai sensi del regolamento REACH e di avere una preregistrazione valida.

Se siete in dubbio e avete bisogno di verificare, contattate le autorità competenti del vostro paese per ulteriori informazioni.

Un utilizzatore a valle ha obblighi di preregistrazione?

Un utilizzatore a valle che non fabbrica o importa sostanze non è tenuto a preregistrare una sostanza soggetta a un regime transitorio ai sensi del regolamento REACH. Tuttavia, l’utilizzatore a valle di una sostanza che non appare nell’elenco delle sostanze preregistrate pubblicato dall’ECHA può notificare all’Agenzia il proprio interesse per la sostanza e i propri recapiti nonché i dati del fornitore attuale. L’ECHA può quindi fornire i recapiti dell’utilizzatore a valle a un dichiarante potenziale.

Il sito web dell’ECHA contiene informazioni e documenti pubblici risultanti dai processi REACH, come l’elenco delle sostanze preregistrate o le notifiche degli utilizzatori a valle, quando queste diventano disponibili, all’indirizzo https://echa.europa.eu/it/information-on-chemicals.

Ulteriori informazioni sugli obblighi degli utilizzatori a valle sono disponibili in 22 lingue dell’UE negli Orientamenti per gli utilizzatori a valle. È possibile modificare la lingua nell’angolo in alto a destra della pagina https://echa.europa.eu/it/guidance-documents.

È possibile modificare i dati inseriti durante una preregistrazione?

Una preregistrazione può essere modificata a eccezione dell’identità della sostanza (Substance ID) e dell’identificatore unico universale (UUID) assegnati alla stessa. È possibile modificare manualmente i recapiti (rappresentante interno e di terze parti), i dati delle sostanze simili, il tonnellaggio e/o la scadenza e le informazioni nel campo relativo alle osservazioni (Remarks) del pre-SIEF.

Ulteriori informazioni su come eliminare, disattivare o modificare una preregistrazione sono riportate in modo dettagliato nella domanda e risposta 346.

Un utilizzatore a valle può partecipare a un SIEF e condividere dati?

Sì, possono e sono incoraggiati a farlo se sono in possesso di dati significativi che saranno utili per i dichiaranti durante la compilazione dei loro fascicoli di registrazione. In pratica, gli utilizzatori a valle devono trasmettere determinate informazioni (identificazione della sostanza, recapiti) all’ECHA al fine di poter essere riconosciuti come titolari di dati relativi a una sostanza, dopo di che l’Agenzia li metterà in contatto con i potenziali dichiaranti.

I titolari dei dati hanno diritto a ricevere un compenso per l’utilizzo dei loro dati nell’ambito della registrazione. Informazioni più dettagliate sono disponibili negli Orientamenti sulla condivisione dei dati all’indirizzo https://echa.europa.eu/documents/10162/13631/guidance_on_data_sharing_it.pdf

Cosa devo fare se nessuno nel pre-SIEF risponde alle mie e-mail?

Un pre-SIEF potrebbe includere numerosi partecipanti, tuttavia può accadere che la maggior parte di loro siano indecisi in merito alla registrazione oppure abbiano deciso di non effettuarla. È questo il caso se l’azienda è contrassegnata dallo stato «Inattivo» (Inactive) nel pre-SIEF; tuttavia, non tutte le aziende utilizzano questa funzionalità.

Se le aziende non rispondono alle vostre e-mail, potreste provare a contattarle in altro modo (nel caso in cui il loro indirizzo e-mail sia obsoleto). Potreste limitare questo approccio alle aziende con le quali avete familiarità e che pensate possano voler procedere con la registrazione.

Potrebbe essere utile anche scaricare il file pdf dei pre-dichiaranti a intervalli regolari in modo da verificare se sono state apportate modifiche ai recapiti. NB: è anche possibile che le comunicazioni siano bloccate come messaggi indesiderati (spam).

Qualora ulteriori tentativi di comunicazione rimangano senza risposta, documentate i tentativi fatti e preparatevi a registrare la sostanza autonomamente. Comunicate i progressi via e-mail agli altri membri del pre-SIEF. Valutate la possibilità di diventare il facilitatore della formazione del SIEF (SFF) in modo da poter indicare nel pre-SIEF come gli altri possono contattavi.

Se la vostra è una sostanza complessa, prendete in considerazione la possibilità che altri fabbricanti/importatori abbiano utilizzato altri identificatori per la sostanza e si trovino in un diverso pre-SIEF. Verificate nell’elenco delle sostanze preregistrate di quali pre-SIEF potreste entrare a fare parte.

Come si effettua la fusione dei pre-SIEF?

Per effettuare la fusione dei pre-SIEF, procedete nel modo seguente:

  • contattate l’altro pre-SIEF;
  • stabilite quale pre-dichiarante deve essere il dichiarante capofila della trasmissione comune;
  • il dichiarante capofila deve creare una trasmissione comune in REACH-IT per la sostanza;
  • il dichiarante capofila deve utilizzare il numero di preregistrazione per creare la trasmissione comune solo se l’identità della sostanza così come specificata nella registrazione preliminare identifica in modo corretto e preciso la sostanza da registrare;
  • ciascun membro della trasmissione comune deve utilizzare gli stessi identificatori chimici del dichiarante capofila per creare la trasmissione comune in REACH-IT;
  • i membri di una trasmissione comune, così come qualunque altro dichiarante, devono presentare singolarmente le informazioni relative all’identità e alle composizioni della propria sostanza. Tali informazioni devono corrispondere alla sostanza così come fabbricata. I membri di una trasmissione comune non devono, pertanto, fornire composizioni generiche né tantomeno duplicati di composizioni fornite da altri dichiaranti.
Come si fa a suddividere un pre-SIEF?

Per suddividere un pre-SIEF, per ciascuna sostanza contemplata dallo stesso pre-SIEF dovete procedere come indicato di seguito:

  • stabilite, fra i pre-dichiaranti con la stessa sostanza, chi deve essere il dichiarante capofila della trasmissione comune;
  • il dichiarante capofila deve creare una trasmissione comune in REACH-IT per detta sostanza;
  • il dichiarante capofila deve garantire quanto più possibile che l’identità della sostanza così come definita nella trasmissione comune possa essere distinta dalle altre sostanze contemplate dal pre-SIEF. A tal fine, è possibile che, anziché utilizzare il numero di preregistrazione, il dichiarante capofila debba inserire manualmente l’identità specifica e corretta della sostanza;
  • ciascun membro della trasmissione comune deve utilizzare gli stessi identificatori chimici del dichiarante capofila per creare la trasmissione comune in REACH-IT;
  • i membri di una trasmissione comune, così come qualunque altro dichiarante, devono presentare singolarmente le informazioni relative all’identità e alle composizioni della propria sostanza. Tali informazioni devono corrispondere alla sostanza così come fabbricata. I membri di una trasmissione comune non devono, pertanto, fornire composizioni generiche né tantomeno duplicati di composizioni fornite da altri dichiaranti.
Is it still possible to benefit from the specific provisions for phase-in substances?

No. The deadline to benefit from the specific provisions for phase-in substances was 31 May 2017.

If you are a first-time manufacturer or importer of a substance, you will need to submit an inquiry to ECHA. You can find further information on the inquiry process under Q&A 444.

Prescrizioni in materia di informazione e metodi di prova e qualità dei dati

In conformità a quali metodi di prova e standard dovrebbero essere condotti i nuovi test?

Quando si eseguono nuove prove è necessario attenersi al regolamento sui metodi di prova (regolamento n. 440/2008 della Commissione) o a qualsiasi altro metodo riconosciuto dalla Commissione europea o dall’ECHA (articolo 13, paragrafo 3, REACH).

Negli allegati da VII a X del regolamento REACH sulle prescrizioni in materia di informazioni standard è prescritto l’uso di varie linee guida OCSE in materia di prove (per esempio, linee guida OCSE 414, 421 e 422).

L’elenco dei metodi OCSE è disponibile al seguente indirizzo: http://www.oecd-ilibrary.org/

Il testo del regolamento sui metodi di prova può essere consultato al seguente indirizzo: http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2008:142:SOM:IT:HTML

Si noti che nel 2016 sono state introdotte modifiche alle prescrizioni di cui agli allegati VII e VIII per i seguenti endpoint: irritazione cutanea e degli occhi, sensibilizzazione cutanea e tossicità dermica acuta, impostare come norma i metodi non testati sugli animali.

È possibile generare informazioni ricorrendo ad altri metodi (articolo 13, paragrafo 3), purché siano soddisfatte le condizioni di cui all’allegato XI. Tra queste si annoverano, tra le altre cose, l’obbligo che i risultati siano sufficienti ai fini della classificazione e dell’etichettatura e/o della valutazione dei rischi, e che sia fornita una documentazione adeguata e affidabile relativa al metodo applicato (cfr. l’allegato XI per ulteriori informazioni).

Esiste inoltre una prescrizione specifica per le prove ecotossicologiche e tossicologiche: sono state condotte nuove prove in conformità con i principi di buona pratica di laboratorio (BPL) definiti nella direttiva 2004/10/CE, dato che nessun’altra norma internazionale è stata riconosciuta finora come equivalente. Per le prove fisico-chimiche può essere auspicabile, ma non è obbligatorio, effettuare le prove in conformità con il principio BPL.

La Guida alle prescrizioni in materia di informazione e alla valutazione della sicurezza chimica contiene specifiche strategie di prova integrate per ciascun endpoint (per esempio, per la tossicità acquatica, per la mutagenicità), che dovrebbero essere consultate prima dell’esecuzione di nuove prove. È possibile consultare questo documento al seguente indirizzo: http://echa.europa.eu/it/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment

Esistono altri «metodi di prova internazionali» riconosciuti dalla Commissione o dall’ECHA e menzionati all’articolo 13, paragrafo 3, REACH?
Per il momento né la Commissione né l’ECHA hanno riconosciuto «altri metodi di prova internazionali» a norma dell’articolo 13, paragrafo 3, REACH.
Esiste un elenco di laboratori detentori di una certificazione BPL?

La Commissione europea ha pubblicato gli elenchi dei centri di saggio ispezionati forniti dalle autorità nazionali di controllo della BPL. È possibile consultare il documento al seguente indirizzo:
http://ec.europa.eu/DocsRoom/documents/8575/attachments/1/translations/en/renditions/native

La certificazione di buona pratica di laboratorio (BPL) spetta alle autorità nazionali competenti che amministrano i programmi di controllo nazionali.

Se il laboratorio è situato nell’UE, in Norvegia o Svizzera, l’autorità competente può essere reperita sul sito web della DG GROW della Commissione europea, al seguente indirizzo:
http://ec.europa.eu/growth/sectors/chemicals/good-laboratory-practice_it

Se il laboratorio si trova in un altro paese occorre consultare la sezione sulla BPL del sito web dell’OCSE:
http://www.oecd.org/chemicalsafety/testingofchemicals/goodlaboratorypracticeglp.htm

Una volta individuata l’autorità di controllo della BPL è possibile richiedere l’elenco dei laboratori certificati BPL nel paese corrispondente.

Inoltre, i laboratori possono essere ispezionati da un’autorità di controllo della BPL anche se situati in un paese che non ha aderito al sistema dell’OCSE di reciproco riconoscimento dei dati. Le informazioni su questi laboratori possono essere richieste all’autorità di controllo della BPL che ha effettuato l’ispezione (cfr. anche Q&A 122 ).

I testi e le banche dati menzionati nella bibliografia sono considerati fonti di dati affidabili sulle sostanze?

In linea di principio è possibile utilizzare dati tratti da una letteratura o da banche dati affidabili e scientificamente accettate, a condizione che la sostanza da registrare e la sostanza descritta in bibliografia siano paragonabili in termini di omogeneità, impurità, dimensioni delle particelle, ecc.

La documentazione relativa alle somiglianze deve essere fornita nel fascicolo di registrazione. I riferimenti alla letteratura o alle banche dati spesso fanno uso di fonti di dati secondarie. Quando vengono utilizzati questi dati, la fonte originale dovrebbe essere citata e verificata da un esperto.

Alcuni utili testi di riferimento e raccolte di dati contenenti dati rivisti tra pari sono elencati in corrispondenza di ciascun endpoint (a, b, c) del capitolo R.7 della Guida alle prescrizioni in materia di informazione e alla valutazione della sicurezza chimica, Orientamenti specifici per endpoint disponibili sul sito web dell’ECHA all’indirizzo: http://echa.europa.eu/it/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment

Per alcuni endpoint i dati raccolti dalla letteratura o dalle banche dati di riferimento possono essere usati autonomamente per soddisfare le prescrizioni in materia di informazioni. Tuttavia, in generale dovranno essere associati ad altri elementi di prova e presentati nell’ambito di un approccio basato sulla forza probante o di un metodo read-across a sostegno della giustificazione proposta per adattarsi alla prescrizione.

Cos’è il sistema MAD (reciproco riconoscimento dei dati) dell’OCSE?

La decisione dell’OCSE relativa al reciproco riconoscimento dei dati (MAD) mette a disposizione dati generati da sperimentazioni di sostanze chimiche in un paese membro dell’OCSE in conformità alle linee guida OCSE in materia di prove e ai principi OCSE di buona prassi di laboratorio (BPL) che sono accettati in altri paesi membri per finalità di protezione della salute umana e dell’ambiente.

Questo sistema interessa anche i paesi non membri dell’OCSE, che hanno fatto richiesta di adesione alla BPL dell’OCSE e al sistema MAD. I paesi non appartenenti all’OCSE si possono suddividere in due gruppi:

  1. paesi aderenti a pieno titolo al sistema MAD dell’OCSE;
  2. paesi provvisoriamente aderenti al sistema MAD dell’OCSE.

I paesi appartenenti al primo gruppo accetteranno i dati generati secondo i criteri MAD provenienti dai paesi membri dell’OCSE e da altri paesi aderenti. Inoltre, i dati di sicurezza di carattere non clinico sviluppati all’interno di tali paesi devono essere accettati dall’OCSE e dai paesi aderenti.

I paesi appartenenti al secondo gruppo devono accettare i dati generati secondo i criteri MAD provenienti dai paesi membri dell’OCSE e da altri paesi aderenti. Tuttavia, durante il periodo di adesione provvisoria, le attività di controllo in materia di BPL condotte dall’autorità di controllo della BPL del paese che aderisce provvisoriamente non devono essere necessariamente accettate dai paesi aderenti a pieno titolo alla decisione MAD dell’OCSE.
http://www.oecd.org/env/ehs/mutualacceptanceofdatamad.htm
 

Quali sono gli studi accettati dall’ECHA come studi conformi alla BPL?

In generale, l’ECHA accetta come dati conformi alle BPL i dati che provengono:

  • dai paesi membri dell’OCSE o dai paesi aderenti a pieno titolo al sistema di reciproco riconoscimento dei dati (MAD) dell’OCSE;
  • da paesi che hanno provvisoriamente aderito al sistema MAD dell’OCSE e nei quali i laboratori sono stati ispezionati congiuntamente dall’autorità di controllo della BPL e da un’autorità di controllo della BPL dell’OCSE.

Gli studi che vengono condotti in un laboratorio situato in un paese non aderente al sistema MAD dell’OCSE possono essere accettati dall’ECHA come studi conformi alla BPL, alle seguenti condizioni:

  • prima della realizzazione dello studio è stata effettuata una verifica ispettiva della conformità alle BPL del laboratorio da parte di:  un’autorità di controllo della BPL dell’UE (compresa la Norvegia ai sensi dell’accordo SEE); o dalle autorità di controllo della BPL di Israele, Giappone e Svizzera con cui l’UE mantiene accordi di reciproco riconoscimento; o da altre autorità di controllo della BPL dei paesi membri dell’OCSE o dei paesi aderenti a pieno titolo al sistema di reciproco riconoscimento dei dati (MAD) dell’OCSE, in base a valutazioni effettuate caso per caso;
  •  è stato verificato che il laboratorio opera in conformità con i principi BPL.

http://www.oecd.org/env/ehs/mutualacceptanceofdatamad.htm

Cfr. anche Q&A 119.

I dichiaranti che presentano una proposta di sperimentazione ai sensi degli allegati IX e X del regolamento REACH possono derogare dagli studi su 28 giorni se sono soddisfatte determinate condizioni. Tuttavia, se non ci sono risultati per uno studio di tossicità con somministrazione ripetuta per 28 giorni poiché viene fatta una proposta di sperimentazione di tossicità con somministrazione ripetuta per 90 giorni, non è possibile derivare un DNEL. Quali misure di gestione del rischio (MGR) temporanee possono essere suggerite in questa situazione?
Le misure di gestione del rischio temporanee devono essere incluse nella relazione sulla sicurezza chimica (RSC) e comunicate agli utilizzatori della sostanza (ai sensi dell’articolo 31 o dell’articolo 32 REACH, sotto forma di scenario d’esposizione (SE) o in altri modi). Tali misure devono descrivere come utilizzare in modo appropriato una sostanza in assenza di sufficienti informazioni tossicologiche e nel periodo di attesa dei risultati della sperimentazione proposta per i rischi a lungo termine. Se non è disponibile un livello derivato senza effetto (DNEL), il dichiarante è tenuto a effettuare una caratterizzazione qualitativa del rischio con riferimento agli usi identificati e all’esposizione prevista, spiegando che le misure sono sufficienti a controllare il rischio (sulla base delle conoscenze disponibili). Le misure di gestione del rischio tipiche applicabili in questo caso sono elencate nella tabella E.3-1 della parte E. Caratterizzazione del rischio della Guida alle prescrizioni in materia di informazione e alla valutazione della sicurezza chimica, disponibile all’indirizzo: http://echa.europa.eu/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment
 
In assenza di informazioni sufficienti sui pericoli relativi alla sostanza, il dichiarante dovrebbe dimostrare di poter garantire il controllo dei rischi riducendo al minimo le emissioni e/o l’esposizione alla sostanza. A tal fine, può usare una combinazione di contenimento e/o aerazione locale per estrazione e/o dispositivi di protezione individuale (DPI) come misure temporanee di gestione del rischio per proteggere i lavoratori dall’esposizione. Vista la provvisorietà di queste misure, i DPI possono svolgere un ruolo di maggior rilievo rispetto alle misure suggerite nella tabella E.3-1 della summenzionata guida.
 
Il dichiarante può aver bisogno di aggiornare la relazione sulla sicurezza chimica e lo scenario d’esposizione una volta ricevuti i risultati della sperimentazione proposta e trovarsi quindi nelle condizioni di ottenere un DNEL (o accertare la necessità di ridurre al minimo le emissioni/l’esposizione se erano stati identificati nella sperimentazione effetti «senza soglia»). Ciò vale in particolare se le misure temporanee facevano affidamento sui DPI anziché su misure di contenimento o su altre misure ingegneristiche.
Quando una sostanza è classificata solo come irritante per gli occhi, è necessario procedere a una caratterizzazione del rischio completa nella valutazione della sicurezza chimica (CSA)?

Non necessariamente. La caratterizzazione del rischio da eseguire nell’ambito di una CSA dipende dal profilo di pericolosità della sostanza. Essa deve tener conto di tutti i tipi di pericolo, non solo quelli che possono comportare una classificazione (punti 0.5 e 6 dell’allegato I, REACH).

In primo luogo, occorre prendere in considerazione ogni pericolo fisico, per la salute e per l’ambiente che sia stato identificato, anche nel caso in cui non sia richiesta una classificazione. A tal fine è necessario, fra l’altro, raccogliere i valori delle concentrazioni prevedibili prive di effetti, i livelli derivati senza effetto o i livelli derivati con effetti minimi (PNEC, DNEL o DMEL), se opportuno.

Occorre prendere in considerazione anche i dati pertinenti circa la scala temporale, i comparti ambientali, le popolazioni umane, gli effetti sulla salute e le vie d’esposizione.

Il DNEL per irritazione/corrosione può essere derivato solo se sono disponibili informazioni dose/risposta. Quindi per gli endpoint come l’irritazione degli occhi, dove non è possibile ottenere un valore DNEL, è necessario un approccio qualitativo alla valutazione e al controllo di tali rischi. Ciò potrebbe verificarsi quando il pH ha determinato la classificazione o quando sono disponibili solo dati QSAR.

Per informazioni relative a tale approccio si rimanda al capitolo R.8 (parte E) e al capitolo R.10 della Guida alle prescrizioni in materia di informazione e alla valutazione della sicurezza chimica. http://echa.europa.eu/it/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment

Nel caso in cui non ci siano altri pericoli, è sufficiente descrivere negli scenari d’esposizione le misure che garantiscono di eliminare o gestire i rischi per gli occhi. Nell’eventualità in cui siano individuati altri pericoli, la valutazione dovrebbe tenerne conto.

La valutazione dell’esposizione e la conseguente caratterizzazione del rischio dovrebbero riguardare tutti i passaggi del ciclo di vita della sostanza a partire dalla fabbricazione e tutti gli usi identificati.

La guida pratica su How to undertake a qualitative human health assessment and document it in a chemical safety report (Come effettuare una valutazione qualitativa della salute umana e documentarla in una relazione sulla sicurezza chimica) è un documento utile quando si affronta la valutazione qualitativa per la salute umana: http://echa.europa.eu/it/practical-guides

Suggerimento: l’uso di Chesar può aiutare a determinare l’ambito di applicazione della valutazione dell’esposizione e il tipo di caratterizzazione del rischio richiesta. Per ulteriori informazioni consultare la parte 1, sezione 6, del manuale degli utenti di Chesar («Chesar User Manual»), disponibile al seguente indirizzo: http://chesar.echa.europa.eu/web/chesar/support/manuals-tutorials

Quali sono i criteri per stabilire se una sostanza è altamente insolubile in acqua o scarsamente solubile in acqua?

Per i test di tossicità acquatica (allegati VII e VIII, sezione 9.1) gli adattamenti descritti nella colonna 2 includono due concetti complementari di solubilità in acqua.

Il concetto di «altamente insolubile in acqua» indica come improbabile il verificarsi della tossicità acquatica; di conseguenza non è possibile stabilire una soglia generale. L’uso di questo concetto ai fini dell’esenzione dagli studi sulla tossicità acquatica richiede una valutazione specifica della sostanza.

Nella dichiarazione di omissione, il dichiarante deve giustificare che è improbabile che si verifichi tossicità acquatica al valore limite della solubilità in acqua. È possibile che siano necessarie informazioni specifiche, come quelle ottenute dagli studi di trasformazione/dissoluzione in acqua o dall’identificazione dei componenti della «Water Accomodated Fraction» (WAF) (cfr. il webinar: Hints and Tips on Physicochemical, environmental and human health related endpoints - Aquatic Toxicity, che fornisce suggerimenti e consigli sugli endpoint fisico-chimici, ambientali e correlati alla salute umana, con particolare riferimento alla tossicità acquatica).

Se il dichiarante non riesce a dimostrare che il verificarsi della tossicità acquatica è improbabile, la sostanza dovrebbe essere considerata «scarsamente solubile in acqua» anziché «altamente insolubile in acqua» e pertanto andrebbero presi in considerazione gli studi a lungo termine.

Il concetto di «scarsamente solubile in acqua» è associato alla necessità di considerare gli studi a lungo termine e non gli studi a breve termine. La Guida alle prescrizioni in materia di informazione e alla valutazione della sicurezza chimica, al paragrafo R.7.8.5 (Orientamenti specifici per endpoint, R.7.b), suggerisce che una solubilità in acqua al di sotto di 1 mg/L o al di sotto del limite di rivelabilità del metodo analitico per questa sostanza dovrebbe essere utilizzata per qualificare la sostanza come scarsamente solubile in acqua e per eseguire gli studi a lungo termine anziché a breve termine:
http://echa.europa.eu/it/guidance-documents/guidance-on-information-requirements-and-chemical-safety-assessment


Per ulteriori dettagli sui test di tossicità acquatica consultare il documento OCSE dal titoloGuidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (Guida ai test di tossicità acquatica di sostanze e miscele difficili), disponibile all’indirizzo:
http://www.oecd-ilibrary.org/environment/guidance-document-on-aquatic-toxicity-testing-of-difficult-substances-and-mixtures_9789264078406-en
 

Prescrizioni in materia di sostanze contenute in articoli

Do I have to register substances in articles?

The registration requirement for substances in articles (as required by Article 7 (1) of REACH) applies only if all the following conditions are met: 

  • the substance is intended to be released during normal and reasonable foreseeable conditions of use; and 
  • the total amount of the substance present in the article exceeds one tonne per producer or importer per year; and 
  • the substance has not yet been registered for that specific use. Pre-registrations, however, do not relieve you from the obligation to register.

If the substance has already been registered for your specific use, then you do not need to register. This registration can be done in your supply chain or any other supply chain. Chapter 3.3.1 of the Guidance on requirements for substances in articles provides advice on how to find out if the substance is already registered for that use.

In order to determine what is an article in this context, especially regarding border line cases between containers and articles, you can consult the Guidance on requirements for substances in articles

Under what conditions and when do I have to notify to ECHA substances of very high concern in articles?

Substances that meet the criteria outlined in Article 57 of the REACH Regulation are commonly referred to as substances of very high concern (SVHCs). You must notify SVHCs present in articles (Article 7(2)) if the following conditions are met:

  1. the substance has been included in the Candidate List of SVHCs for authorisation; and
  2. the substance is present in articles above a concentration of 0.1% weight by weight (w/w); and
  3. the total amount of the substance in those articles (i.e. those containing more than 0.1% (w/w) of the Candidate List substance) exceeds one tonne per producer or importer per year; and
  4. exemptions do not apply.

Two specific exemptions can apply to the notification of substance in articles:

(a) exemption based on exclusion of exposure to humans or the environment during normal or reasonably foreseeable conditions of use and disposal (Article 7(3)) and

(b) exemption for substances already registered for that use (Article 7(6)).

You must notify Candidate List substances in articles at the latest six months after the SVHC has been included on the Candidate List for authorisation (Article 7(7)).

The Candidate List will be updated continuously when substances that meet the criteria of Article 57 are identified.

You can find further information at: http://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles.

The Candidate List can be found at: http://echa.europa.eu/candidate-list-table.

As Article 7(6) of REACH states "Paragraphs 1 to 5 shall not apply to substances that have already been registered for that use" does it refer to the same supply chain or to different supply chains?
Provided that the substance has been registered by any manufacturer/importer for that specific use, paragraphs 1 to 5 of Article 7 of the REACH Regulation shall not apply. This means that it is not relevant whether the registration was done within the same supply chain or within another supply chain.
Can I already rely on the provisions of Article 7(6) of REACH when a substance in an article has been pre-registered?
No, because Article 7(6) of the REACH Regulation only applies if the substance has already been registered for that use.
What is an intended release of a substance from articles?

A substance is intended to be released from articles if it fulfils an accessory function which would not be achieved if the substance was not released. A scented children's toy, for example, is an article with intended release of substances, because fragrance substances contained in the toy are released in order to fulfil an accessory function, namely to scent. Consequently, the release of a substance because of ageing of articles, because of wear and tear or as an unavoidable side-effect of the functioning of the article, is generally not considered as an intended release, as the release as such does not provide a function in itself.

An intended release of a substance from an article has furthermore to occur under normal or reasonably foreseeable conditions of use. This means that the substance release has to occur during the service life of the article. Hence, a substance release during the production or disposal phase of the article's life cycle is not an intended release. Similarly, a release in an accident or due to any form of misuse which is not in accordance with the use instructions of the article, does not occur under normal or reasonably foreseeable conditions of use and is therefore not considered to be an intended release.

May steel semi-finished products such as slabs, blooms and billets be considered as articles?
The transition point of steel and steel semi-finished products from substances/mixtures to articles during processing is to be determined by comparing the importance of physical and chemical characteristics for achieving the object's function. If it can be unambiguously concluded that the shape/surface/design are more relevant for the function than the chemical composition, the object that it is assessed is an article. If the shape, surface or design is of equal or less importance than the chemical composition, it is a substance or mixture. To determine whether or not steel semi-finished products constitute an article one can use the indicative questions given in Section 2.3 - 'Deciding whether an object is an article or not' of the Guidance on requirements for substances in articles http://echa.europa.eu/guidance-documents/guidance-on-reach
 
ECHA also advises industry to consult sector-specific guidance documents provided by business associations. However, it is up to the individual companies to examine their specific situation and determine whether their product may be considered as an article.
Is there any notification fee for the submission of a notification of Substances of Very High Concern (SVHC) in articles per Article 7 (2) of REACH?
There is no fee charged for the notification of SVHC in articles.
I have stopped production/import of the article containing a Substance of Very High Concern (SVHC). Do I have to notify?

If the production/import ended before the SVHC was included in the Candidate List or before the notification obligation starts to apply (i.e. 6 months after a substance has been included in the Candidate List or 1 June 2011 for substances placed on the Candidate List before 1 December 2010) then you do not have to notify. However, you may still have obligation, under Article 33 of REACH, to provide the recipient of the article, or the consumer upon request, with sufficient information to allow safe use of the article, including, as a minimum, the name of that substance. 

Do I have to consider the tonnage produced/imported before the Substance of Very High Concern (SVHC) was put on the Candidate List for the calculation of the tonnage in accordance with Article 7 (2) of REACH?
For articles which have been produced/imported for at least three consecutive years, the tonnage to be reported must correspond to the average tonnage of the substance in the article produced/imported during these three full years. If the substance in the article has only been produced or imported for two full years, the average of these two full years must be notified. However, if the substance in the article has been produced or imported only since the previous calendar year, the tonnage will be calculated based on the previous calendar year only and no averaging will be made.
 
For instance, substances that had been placed on the Candidate List before 1 December 2010 must have been notified by the producer or importer of the article by 1 June 2011. The producer or importer should have provided the average tonnage of the three or two preceding years, or the tonnage of 2010, depending on for how many consecutive years they had imported or produced the article. 
 
Thus, there are situations, where volumes of the substance predating the inclusion in the candidate list are considered in the tonnage calculation for the notification of a substance in an article.
 
Where production/import of the article starts in the current year, you are advised to notify as soon as the 1 tonne threshold is exceeded. In that case please indicate an expected tonnage range for the whole year.
Do article producers and importers notify only once according to Article 7 (2) of REACH, or should the notifications be updated?
While registrations of substances in articles must be updated with relevant new information, there is no legal requirement to update a "notification of substances in articles" dossier. However, ECHA recommends that notifiers update their notification dossier whenever there is a change in the information that was notified. Furthermore, it is also in the interest of the notifier to maintain an updated dossier, because based on the notification, ECHA may take a decision according to Article 7 (5) of REACH to require producers or importers of articles to submit a registration.
How can producers or importers of articles find information on whether an SVHC has already been registered for use in a particular article and whether the exemption in Article 7(6) of REACH thus applies?
The possibilities that companies have to verify whether a substance has been registered for a particular use are clarified in the Guidance on requirements for substances in articles. It should be noted that the sameness of both the substance identity and the use must be ensured. The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach
 
Sources of such information are e.g. the safety data sheets, supply chain communication and trade associations. The ECHA website also provides information from registration dossiers. The amount of available information will often be larger for EU-producers of articles than for importers of articles. Thus it may often be easier - particularly for importers of articles - to notify an SVHC in an article than to document that the substance has already been registered for the particular use in the specific article.
Is a permanent magnet a substance/mixture or an article under REACH?

A permanent magnet should be considered as a substance or a mixture (and not an article) under REACH. This is because its shape, surface or design are less relevant for its function than its chemical composition. As a substance or a mixture, a permanent magnet is subject to the applicable provisions of the REACH and CLP regulations (e.g. it needs to be appropriately packaged and labelled).

Permanent magnets are used in different sizes and forms. They should create a (strong) permanent magnetic field and be stable to perform their main function of attracting or repelling other magnetic objects through a magnetic force (e.g. in cupboards to keep a door closed). They should also have high magnetic coercivity (i.e. they should be difficult to demagnetise).  

The materials to be used to produce permanent magnets should either be either materials with permanent magnetic fields or materials with a susceptibility to be magnetised by applying an external magnetic field. The latter should also retain the imprinted magnetic pattern (high magnetic coercivity). 

The magnetism is one example of a physical property that results from the chemistry of the materials an object is made of, given in the Guidance on requirements for substances in articles (subchapter 2.2). The Guidance also states that such material characteristics or properties are not to be confused with the shape, surface and design of an object.

The stability (magnetic coercivity) and the strength of the created permanent magnetic field appear to be the most important properties of a permanent magnet. Therefore, the magnetic properties of the permanent magnet, which are strongly related to its chemical composition, determine its function.

Are ammunition cartridges designed to launch a projectile (e.g. a bullet) considered as ‘articles' under REACH?
Yes, ammunition cartridges that are designed to launch a bullet are considered to be articles with an integral substance/mixture (the propellant) because the shape, surface and design of such ammunition cartridges determine their function to a greater degree than does its chemical composition.
It should be noted that this answer is limited to ammunition cartridges that are designed to launch a projectile (i.e. a bullet). It does not necessarily apply to ammunition where the function of the object is the deliberate release of a mixture (i.e. flares, gas grenades, etc.). 
 
This Q&A was first published on ECHA website on 04/08/2016.
When do I have to communicate information on Candidate List substances in articles down the supply chain and to consumers? What information do I need to communicate?

If you are a supplier of an article containing a substance, you have to provide to the recipient of the article (Article 33(1)) or to a consumer (Article 33(2)) relevant safety information, available to you, when both the following conditions are met:

  • The substance is included in the Candidate List for authorisation, and
  • The substance is present in the article produced and/or imported above a concentration of 0.1% (w/w).

The information is to be provided to the recipient of the article, i.e. industrial or professional users and distributors, when the article is supplied for the first time after the inclusion of the substance into the Candidate List and to the consumer upon request by that consumer, within 45 calendar days of that request and free of charge.

The communication of information at the request of a consumer is independent of whether the article was purchased by that particular consumer.

The information you should communicate must be sufficient to allow safe use of the article, considering all life cycle stages of the article including disposal. Section 3.4.1 of the Guidance on requirements for substances in articles describes in detail which information should be communicated.

If no particular information is necessary to allow safe use of the article containing a Candidate List substance, e.g. when exposure can be excluded at all life cycle stages of the article including disposal, as a minimum the name of the substance in question has to be communicated to the recipients of the article or to consumers.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

Do the articles assembled or joined together in a complex object remain articles?

In the Guidance on requirements for substances in articles, the term “complex object” refers to any object made up of more than one article. In complex objects, several articles can be joined or assembled together in various manners. For example, they can be mechanically assembled (e.g. pair of (metallic) scissors, foldback clips) or joined using substance(s)/mixture(s) (e,g. block of sticky notes, glued chip in a bank card, unpainted bicycle frame formed by welding together multiple steel tubes). The more articles it is made of, the more complex an object becomes.

Articles that are assembled or joined together in a complex object remain articles, as long as they keep a special shape, surface or design, which is more decisive for their function than their chemical composition, or as long as they do not become waste (as defined in the Waste Framework Directive - Directive 2008/98). An importer or a supplier of a complex object (e.g. foldback clip) is importer or supplier of the various articles the complex object is made from, and must therefore comply with the applicable communication and notification obligations for each one of them (e.g. the bent strip of steel and the two metallic wire handles of the foldback clip). Whether the complex object is an article depends on whether it fulfils the criteria of the definition of an article. 

How do I determine the concentration of a Candidate List substance in an article?

The determination of the concentration of a Candidate List substance, to check whether it is above the 0.1% w/w threshold or not, is essential to check whether communication and notification obligations apply.

Table 5 in the Guidance on requirements for substances in articles illustrates and explains in detail several scenarios on how to determine the concentration of a Candidate List substance (weight by weight (w/w)) in an article or in articles incorporated in a complex object (any object made up of more than one article). In summary:

  • Scenario I. Article made from a Candidate List substance as such or in a mixture: the concentration is calculated over the total weight of the article (e.g. plastic chair produced by injection moulding)
  • Scenario II.  Candidate List substance as such or in a mixture used for joining two or more articles (complex object): the concentration of the Candidate List substance is calculated over the total weight of the complex object (e.g. unpainted bicycle frame formed by welding together multiple steel tubes, using a mixture containing the substance)
  • Scenario III. Candidate List substance in coatings (e.g. paint, lacquer, varnish, functional coating) -  III. A) Fully coated article; III. B) Partially coated article; III. C) Coated complex object: the concentration of the Candidate List substance in the (fully/partially) coated article is calculated over the total weight of the coated article or of the complex object
  • Scenario IV.  Very complex objects (e.g. sofa, bicycle, mobile phone, car and aircraft): the calculation rules set out for scenarios I to III above apply for each article or simpler complex object.

The Guidance on requirements for substances in articles is available on the ECHA website at: http://echa.europa.eu/guidance-documents/guidance-on-reach

Rappresentante esclusivo di un fabbricante non appartenente all’UE

Who can appoint an only representative?
According to Article 8(1) of REACH, a natural or legal person established outside of the EU who manufactures substances (to be used on their own, in mixtures and/or to produce articles), formulates mixtures or produces articles, can nominate an only representative located within the EU to carry out the required registration of their substances that are imported (as such, in mixtures and/or in articles) into the EU. Distributors are not mentioned in Article 8(1) of REACH and thus cannot appoint an only representative.
The reference to the EU covers both the EU countries and the EFTA countries that have adhered to the EEA (European Economic Area) Agreement, that is Iceland, Liechtenstein and Norway.
The only representative will have to fulfil the registration obligations of importers (Title II of REACH) and comply with all other obligations of importers under the REACH Regulation. More information on the only representative role is provided in section 2.1.2.5- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach
Who can be appointed as an only representative?

A non-EEA company (that can appoint an only representative, see FAQ ID=15) may, by mutual agreement, appoint a natural or legal person established in the European Economic Area (EEA) to act as his only representative. According to Article 8(2) of REACH this representative shall comply with all obligations of importers under REACH. Therefore the only representative is required to have sufficient background in the practical handling of substances and the information related to them. More information on the only representative is also provided in section 2.1.2.5- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.

What is meant by the "sufficient background" of an only representative?
There are no detailed requirements or criteria regarding what is regarded as "sufficient background in the practical handling of substances and the information related to them" other than what is laid down in Article 8(2) of REACH.
Is there a special procedure to appoint an only representative?
The issue of becoming an only representative is a question of mutual agreement between the "non-EU manufacturer" and the natural or legal person established in the EU who is being appointed as an only representative.
"Non-EU manufacturers" need to send a letter confirming this appointment to their only representative who must have it available in case of inspection by the relevant Member State's enforcement authority. No such letter has to be sent to ECHA. However, when compiling the registration dossier in IUCLID 5 the only representative is advised to attach this letter of appointment to the registration dossier in the field "Official assignment from non EU manufacturer" in section 1.7. More information on the duties of the only representative is provided in section 2.1.2.5- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
In addition the "non-EU manufacturer" shall inform the importer(s) within the same supply chain of the appointment of the only representative according to Article 8(3) of the REACH Regulation. These importers shall be regarded as downstream users.
Can an only representative represent more than one company?

Yes, an only representative can represent one or several non-EEA companies that manufacture substances, formulate mixtures or produce articles which are exported to the European Economic Area (EEA), even for the same substance. More information on the duties of the only representative is provided in section 2.1.2.5- 'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.

How can "non-EU manufacturers" help their only representative or importers to prepare for registration?
The importer or the only representative is responsible for submitting a registration dossier or a pre-registration to take advantage from the extended registration deadlines for phase-in substances. In order to assist these actors under REACH, the "non-EU manufacturer" may wish to make himself aware of the information requirements laid down in REACH and start to collect the relevant information. This may include correct identification (CAS or EINECS/ELINCS/NLP) number and naming of the substance and information on its composition. This is explained in more detail in the Guidance for identification and naming of substances under REACH and CLP: http://echa.europa.eu/guidance-documents/guidance-on-reach.
The "non-EU manufacturer" may also assist in providing all available information regarding the intrinsic properties of the substances (see Annex VII to XI of REACH). However, these supporting measures of the "non-EU manufacturer" cannot relieve the only representative or the importer from the duty to comply with all relevant obligations of the REACH Regulation.
More information for "non-EU manufacturers" can be found at: http://echa.europa.eu/contact/helpdesk-contact-form/enquiry-on-reach-from-non-eu-countries
As an only representative, do I need to specify in the registration dossier the identity of the "non-EU manufacturer" I am representing?
An only representative must be able to document who he is representing (i.e. the name of the non-EU manufacture should be given in section 1.7 of IUCLID) and is advised to attach a document from the "non-EU manufacturer" appointing him as only representative in section 1.7 of IUCLID. It is not mandatory to include this information in the registration dossier, but it needs to be presented to the enforcement authorities upon request. Furthermore an only representative is advised to include the "list of importers" in section 1.7 in IUCLID.
Have registered a substance as an only representative of a non-EU manufacturer. Does a change of the importers of the non-EU manufacturer trigger the need for an update of the registration, and would this update be subject to a fee?
The change of importers of a substance supplied by a non-EU manufacturer who appointed an only representative to register this substance does not trigger the requirement to update the list of importers indicated in section 1.7 of the IUCLID 5 dossier. However, the only representative is required, in accordance with Article 8 (2) of REACH, to keep available and up-to-date information on quantities imported and customers sold to.
Information on the importers may be reported in section 1.7 of IUCLID 5. Practical information on how to do this is provided in the Data Submission Manual 5, section 4.1.7: http://echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals
The update of this list of importers is not subject to any fee.
What are the obligations of polymer importers (or ORs appointed by non-EU polymer manufacturers), if an OR has already been appointed by the non-EU monomer producer up the non-EU supply chain, but this OR does not want to take on the legal responsibility envisaged in Article 8 of REACH for the polymer importers?
In the case of polymer imports, the condition "have already been registered up the supply chain" in Article 6(3) REACH can only be fulfilled if an OR appointed up the non-EU supply chain (e.g. the OR of the non-EU monomer manufacturer) has decided to also cover the polymer imports with their registration (i.e. included the volumes concerned in their registration and took over the obligations in Article 8(2) and 8(3) of REACH). If the OR of the non-EU monomer manufacturer decides not to take legal responsibility for these volumes, the polymer importer cannot rely on the exemption from registration and is obliged to register the volumes of monomer they import. Alternatively, an OR appointed by the non-EU polymer manufacturer could register on behalf of the polymer importers.
If ORs have been appointed to fulfil the registration obligations of non-EU manufacturers but not their authorisation obligations, can the EU importer instead apply for authorisation? If so, under which role (importer or downstream user (DU))?

EU importers of a non-EU manufacturer can apply for an authorisation irrespective of whether they are covered by an OR for registration of the Annex XIV substance. If the appointment of the OR does not extend to also cover the fulfilment of the obligations of the importers with regard to authorisation, then the importers themselves can apply for an authorisation. In such a case, the importers will apply in their role as importers of an Annex XIV substance. Furthermore, the importers are not required to indicate the name of the non-EU manufacturer or the OR in their application for authorisation sent to ECHA, since the OR's appointment and their respective obligations are limited to the registration of the Annex XIV substance.

I represent a manufacturer based outside the EU. The company will be absorbed by another non-EU company. As an only representative, do I have to notify ECHA about this change?

Yes, you need to notify ECHA about this change. You represent the non-EU manufacturer and, therefore, you need to communicate changes in their legal personality. You can notify ECHA using the legal entity change functionality in REACH-IT.

To change the legal personality in this case you need to:

  • Create a new account in REACH-IT for your company to represent the new legal entity, reflecting their size. Note that in the "Company Size" information, you must indicate the size of the non-EU/EEA manufacturer you are representing and not the size of your own legal entity.
  • Initiate a legal entity change (only representative changes)
  • Include documents which clearly explain how you represent the new non-EU manufacturer
  • Update the IUCLID files, in particular section 1.7 ‘Only Representative information'
  • Submit a spontaneous update in the new legal entity to report the change in the dossier

You may need to pay a fee to complete the process. More information related to the outcome of a legal entity change can be found at Q&A 388.

Registrazione REACH

Who has to register substances?

Only a natural or legal person established within the European Economic Area (EEA)/EU can be a registrant. Registration must take place when this person:

  1. manufactures a substance within the EU in quantities of 1 tonne or more per year;
  2. imports a substance into the EU of quantities of 1 tonne or more per year; or
  3. has been appointed as an only representative according to Article 8 of REACH (see FAQs on Only Representative of non-EU manufacturer).

The national law of each country provides the specific provisions concerning natural or legal personality and when such a natural or legal person is established in its territory.

A company not established within the EU does not have direct obligations under REACH. For obligations of a non-EU company, please see to FAQ 12.

In order to identify your obligations, please use the Navigator tool:
http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations

This tool is designed to help companies in determining their obligations under REACH and find the appropriate guidance on how to fulfil them.

In case of an international company, who is the registrant?

International companies sometimes have several daughter companies in the EEA/EU, often spread over several countries. If these subsidiaries of the parent company are separate legal entities from it, (a natural or legal person as defined under applicable national law), then each of those must determine if they qualify as registrant under REACH.Please see FAQ ID=27 on who has to register a substance.

Which substances have to be registered?
Registration is required for all substances:
- as defined in Article 3(1) of REACH;
- manufactured in or imported into the EU in quantities of 1 tonne or more per registrant per year;
- unless they are exempted from registration or regarded as being already registered, according to provisions in Articles 2, 9, 15 or 24 of the REACH Regulation;
- irrespective of whether they are classified as dangerous or not.
If you want to know whether you have to register a substance you should first consult section 2.2- 'What to register?' of the Guidance on registration. There you will also find information on substances exempted from registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
In addition, the Navigator tool can help to clarify the registration obligations for your specific substance: http://echa.europa.eu/support/guidance-on-reach-and-clp-implementation/identify-your-obligations.
Do I have to register alloys?
The REACH Regulation refers to alloys as "special mixtures" (Recital (31), Annex I (0.11.), as amended by Regulation (EC) No 1272/2008). Therefore, an alloy is to be treated in the same way as other mixtures under REACH, which means that the alloy as such is not subject to registration but the alloying elements (e.g. metals), irrespectively of the production process of the alloy are. However, components which are not important for the properties of the alloy should be considered as impurities (i.e. they are part of a substance in the mixture) and therefore need not be registered separately. Please note that intermetallic compounds are often wrongly regarded as alloys, although they have a well defined stoichiometry. Such substances are listed in EINECS (e.g. "aluminium, compound with iron (1:1)", "iron, compound with titanium (2:1)", etc.) and cannot be regarded as mixtures, therefore these intermetallic compounds have to be registered as such. This means that e.g. separate (pre-)registrations of the substances Al and Fe do not cover the substances "aluminium, compound with iron (1:1)" or "aluminium, compound with iron (1:3)". For each intermetallic compound with a different metal ratio a separate (pre-)registration is required.
Do I have to register a substance occurring in nature if I have to apply a process to extract this substance?
Substances occurring in nature are exempted from the duty to register in accordance with Article 2(7)(b) and Annex V, point 8 of REACH, as long as they are not chemically modified, not classified as dangerous in accordance with Directive 67/548/EEC, nor substances of very high concern, such as PBT or vPvB substances. If a process is applied to extract such a substance, it has to be verified whether the process applied is one of those listed in Article 3(39) of the REACH Regulation. If this is the case, the substance still qualifies as substance that occurs in nature that does not have to be registered.
The processes mentioned in Article 3(39) of REACH are manual, mechanical or gravitational processes, dissolution in water, flotation, extraction with water, steam distillation, heating solely to remove water and extraction from air. Please note that extraction with solvents other than water, like e.g. hexane or ethanol, are not covered by Article 3(39) of REACH. Substances which are extracted with these solvents do not qualify as a substance that occurs in nature and cannot be exempted from registration on the basis of Annex V, point 8 of REACH.
Lavender oil, for example, is extracted from flowers of certain species of lavender (which occur in nature) by means of steam distillation. The subsequent spontaneous separation of oil and water allows an easy isolation of the lavender oil. As this extraction process is mentioned in Article 3(39) of REACH, the lavender oil can be regarded as a substance that occurs in nature.
On the contrary, chrysanthemum oil, for example, which is extracted from chrysanthemum blossoms and leaves (which occur in nature) with a solvent mixture of water and ethanol (1:10), cannot be regarded as a substance that occurs in nature.
In general, it is important to remember that it is up to the manufacturer to assess the process applied and to determine if the definition of Article 3(39) of REACH is applicable or not.
Have PORD exemptions under Directive 67/548/EEC been transferred into REACH?

National Process Orientated Research and Development (PORD) exemptions for the notification of substances under Directive 67/548/EEC are no longer valid under REACH since 1 June 2008, because there are no such notifications under REACH. Therefore, to benefit from the registration exemption, manufacturers or importers of substances or producers of articles wishing to continue their PORD activities need to submit a PPORD notification (REACH, Article 9). For guidance on how to prepare and submit a PPORD notification in practice, please consult the Data Submission Manual 1, available at:

http://www.echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-manuals

Does a potential registrant have to register a substance he is manufacturing or importing if this substance has previously been notified under Directive 67/548/EEC by another manufacturer or importer and is, thus, regarded as registered under the REACH Regulation?

Yes, a notification under Directive 67/548/EEC as amended by Directive 92/32/EEC is nominal so that only the notifier benefits from the provision that notified substances are being considered registered. Therefore, any other parties manufacturing or importing the substance in quantities of more than one tonne per year who have not notified this substance, must register it unless another exemption from the duty to register applies. More information on notified substances can be found in Article 24 (2) of the REACH Regulation and in Section 2.2.4.3- 'Notified substances according to Directive 67/548/EEC' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.

Will a registration under the REACH Regulation be required for substances that are manufactured within the EEA but exported 100% outside of the EEA?
Yes. Article 6 of the REACH Regulation requires a manufacturer of a substance in quantities of more than 1 tonne per year to submit a registration, irrespective of whether this substance will subsequently be exported outside of the EEA. Therefore, substances manufactured in the EEA above this limit that do not meet any of the criteria for exemption from registration in accordance with Article 2 of the REACH Regulation and which are subsequently exported to non-EEA countries must be registered. The rationale for this duty is that the exposure resulting from manufacture and any other activity before export could be relevant for workers and the environment in the EEA.
Do I have to register chemically surface treated substances?
The surface treatment of a substance is a "two dimensional" modification of macroscopic particles. A "two dimensional" modification means a chemical reaction between the functional groups only on the surface of a macroscopic particle with a substance which is called a surface treating substance.By this definition it becomes clear that this kind of modification means a reaction of only a minor part (surface) of a macroscopic particle with the surface treating substance, i.e. most of the macroscopic particle is unmodified.
Therefore a chemically surface treated substance cannot be regarded as a mixture nor be defined by the criteria of the Guidance for identification and naming of substances under REACH: http://echa.europa.eu/guidance-documents/guidance-on-reach.
With the same reasoning, a chemically surface treated substance could not be reported for EINECS nor be notified according to Directive 67/548/EEC because it was covered by the separate EINECS entries of both the basis substance (macroscopic particle) and the surface treating substance.Taking this decision up under REACH means a consequent continuation of former decisions. Using the same line of arguments, chemically surface treated substances should not be registered as such under REACH, but the following requirements should be fulfilled:
1. Registration of the basis substance (macroscopic particle)
2. Registration of the surface treating substance
3. Description of the use "surface treatment" in the registration dossier of the surface treating substance and in the registration dossier of the basis substance
4. Any specific hazards or risks of the surface treated substance should be appropriately covered by the classification and labelling and by the chemicals safety assessment and resulting exposure scenarios.
Do I have to register substances used in medicinal products?2
According to Article 2(5)(a) of the REACH Regulation substances used in medicinal products for human or veterinary use within the scope of the relevant EU legislation are exempted from the Registration Title of the REACH Regulation (Title II). More explanation is provided for in Section 2.2.3.2- 'Medicinal products' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
Substances fulfilling the conditions of Article 2(5)(a) of the REACH Regulation are also exempt from the Titles on Downstream Users, Evaluation and Authorisation (Titles V, VI and VII of the Regulation).
Importantly, substances are exempted from these Titles only to the extent that they are used in medicinal products in accordance with Regulation 726/2004, Directive 2001/82 and Directive 2001/83. Quantities of the same substance used for other purposes are not exempted.
The exemption covers the manufacture (in the EU) of substances in medicinal products that are exported; and the manufacture (in the EU) of active substances within the scope of EU legislation on medicinal products that are exported. The exemption also applies to imports of substances in medicinal products and imports of active substances within the scope of the EU rules on medicinal products.
Intermediates that are not present in the medicinal product (as defined in Regulation 726/2004, Directive 2001/82 and Directive 2001/83) are not exempted from registration. 
May pre-registered substances that are manufactured or imported before the relevant registration deadline be placed on the market after this deadline without a registration?

REACH imposes registration obligations only on manufacturers or importers (and, in specific cases, on producers or importers of articles). The registration obligation does not apply to downstream users or distributors. Therefore, the registration obligation does not apply to you if you have:

  • manufactured or imported pre-registered substances before the registration deadline; and
  • completely ceased such activities and only used the substances and/or supplied them after that.

For example, importers for whom the last batch of the substance was imported on 31 May 2018, at the latest, may continue to use and/or supply that substance after the deadline without a registration, without time-limitation. Since the pre-registered substance has not been registered, there is no obligation to notify ECHA of the cessation of manufacture/import. Article 50(2) and (3) of the REACH Regulation does not apply to this situation.

If you have not ceased your activities before the registration deadline, you have an obligation to register the substance according to Article 6 of REACH.

If you are a downstream user (or any other actor down the supply chain) who is not subject to the registration obligation, you can continue to use, without time-limitation, and/or supply quantities of the substance that were manufactured or imported before the registration deadline.

For the obligations of a downstream user or distributor and whether they are obliged to check the registration status of the substances on their own or in a mixture, please see Q&A 155

Is a metal hydroxide manufactured from the metal oxide covered by the exemption from registration in Annex V, point 6 of the REACH Regulation?
According to Annex V, point 6 of the REACH Regulation hydrates of a substance or hydrated ions, formed by association of a substance with water are exempted from registration, provided that the substance (i.e. the anhydrous form) has been registered by its manufacturer or importer.
 
Hydrates of a substance are characterised by the fact that water molecules are linked by molecular interactions, in particular by hydrogen bonds, to other molecules or ions of the substance. For the purposes of Annex V, hydrates and water free forms (anhydrous) of compounds shall be regarded as the same substance (e.g. CuSO4.5H2O and CuSO4).
 
In contrast, a metal hydroxide (e.g. Ca(OH)2) and a metal oxide (e.g. CaO) cannot be regarded as the same substance as both substances have different structures, regardless of the manufacturing process. The formation of the hydroxide involves forming new covalent bonds, which is different from forming a hydrate which only involves weak intermolecular bonds. Therefore a metal hydroxide manufactured from the metal oxide is not covered by the exemption from registration in Annex V, point 6.
Are substances that are banned under Regulation (EC) No. 2037/2000 (on substances that deplete the ozone layer) subject to (pre-) registration?

Yes. Substances are not exempted from (pre-)registration on the grounds that they are within the scope of Regulation (EC) No. 2037/2000 on substances that deplete the ozone layer. FAQ ID=30 explains which substances have to be (pre-)registered.

Is a registrant required to update their registration dossier with a new analysis dataset each time the substance is imported from a new non-EU manufacturer?
There is no explicit legal obligation for registrants to update their registration dossier every time an import is made from a new non-EU source. However, according to Article 22(1)(b) of REACH, there is a legal obligation to update the composition of the substance as given in Section 2 of Annex VI. The registrant has to assess the sameness of the substance every time an import of the substance is made from a new source, according to Guidance for identification and naming of substances available on the ECHA website.
There are three possible outcomes of this assessment:
 
1. Registrants find that the substance has the same impurity profile as previous imports and is already registered by them. They do not have to update the registration dossier for the substance.
 
2. Registrants find that the substance has a different impurity profile from previous imports. They then have to update the relevant sections of the registration dossier (e.g. concentration ranges or changes in C&L) with the new composition of the substance.
When do I have to register my substance?

Information on the various aspects that need to be taken into account before registration is provided in Section 2.3- 'When to register?' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.

The REACH Regulation created a transition regime involving a pre-registration phase for the registration of substances (Section 2.3.1.1- 'Phase-in substances' of the Guidance on registration). Depending on its intrinsic properties and its tonnage, a pre-registered substance needed to be registered before either of the relevant previous deadlines in 2010 and 2013, or by the last one on 31 May 2018.

Substances that were not pre-registered must be registered before the manufacture or import can continue at an annual quantity of one tonne or more. Before the registration of such substances, the manufacturer or importer has to make an inquiry to ECHA regarding any previous registration for that substance.

Upon registration, the registrant may have to wait for three weeks after the registration dossier is submitted before starting or continuing the manufacture or import of the substance (Article 21 of the REACH Regulation).

Come calcolo il tonnellaggio?

Ogni dichiarante deve calcolare il tonnellaggio annuale per il fascicolo di registrazione. Il tonnellaggio annuale è calcolato in termini di volume per fabbricante/importatore per anno di calendario, salvo diversa indicazione. Per le sostanze soggette a un regime transitorio che sono state importate o fabbricate per almeno tre anni consecutivi, i quantitativi annuali si calcolano sulla base dei volumi medi di fabbricazione o di importazione dei tre anni di calendario precedenti (articolo 3, paragrafo 30, del regolamento REACH). Una guida dettagliata ed esempi pratici sono forniti nella sezione 2.2.6 «Calcolo del volume da registrare» della Guida alla registrazione: http://echa.europa.eu/it/guidance‑documents/guidance‑on‑reach

 

Can I register for a tonnage band higher than the actual tonnage of the substance?

Yes. Companies are free to register a substance for a tonnage band which is above the actual tonnage of the substance. This is also reflected in Section 2.2.6.3- 'Calculation of the total volume' of the Guidance on registration http://echa.europa.eu/guidance-documents/guidance-on-reach.

This section clarifies that companies are free to register a substance for the intended tonnage band. A registration at a higher tonnage band will trigger a higher registration fee in accordance with Regulation (EC) No 340/2008. In addition, the technical dossier will need to comprise all the information required for the registered tonnage band. Practical advice on how to complete a IUCLID dossier is provided in the Manual: How to prepare registrations and PPORDS at: http://echa.europa.eu/manuals.

How do I register my substances and do I need IUCLID?

All registrations shall be submitted to ECHA. This shall be done using the REACH-IT Portal. For more information please visit the REACH-IT section of the ECHA website: http://echa.europa.eu/support/dossier-submission-tools/reach-it.

According to Article 111 of the REACH Regulation, registration dossiers have to be submitted in the format of IUCLID (International Uniform Chemical Information Database). IUCLID is a software tool for companies to store data on chemicals and prepare registration dossiers. Registrants are not obliged to use the IUCLID software, but they must submit their registration in the IUCLID format.

The IUCLID software is downloadable free of charge from the IUCLID website http://iuclid6.echa.europa.eu/home.

A quanto ammonta la tariffa di registrazione?

La tariffa di registrazione per una sostanza dipende dalla fascia di tonnellaggio di registrazione, dalle dimensioni dell’azienda e dal tipo di presentazione. Inoltre:

  •  tariffe e oneri inferiori si applicano in caso di trasmissioni comuni, rispetto a quanto addebitato in caso di trasmissioni distinte. Ciò non si  applica nel caso in cui si decida di rinunciare alla trasmissione comune;
  •  le PMI beneficiano di una tariffa ridotta in tutte le categorie;
  •  una tariffa aggiuntiva viene riscossa per la riservatezza.

Non viene richiesto il versamento di alcuna tariffa per la registrazione di sostanze in quantitativi compresi tra 1 e 10 tonnellate all’anno nell’ambito di una registrazione contenente la totalità delle informazioni di cui all’allegato VII, che rappresenta l’insieme di base degli obblighi di informazione per le sostanze fabbricate o importate in quantitativi pari o superiori a 1 tonnellata.
Tutte queste disposizioni sono specificate nell’articolo 74 del regolamento REACH. Le tariffe sono sviluppate nel regolamento relativo alle tariffe della Commissione (n. 340/2008). Ulteriori informazioni sono disponibili nella sezione delle domande frequenti (Q&As ), sezione REACH-IT, alla voce «Invoicing» (fatturazione).
http://echa.europa.eu/qa-display/-/qadisplay/5s1R/view/reach-it/invoicing.

Can a Non-EEA manufacturer of a substance register under REACH?
No. The obligation to register a substance applies only to actors established within the EEA. Thus, the registration of substances imported into the EEA on their own, in mixtures or, in certain cases, in articles will have to be done by the importer established in the EEA. This implies that each individual importer needs to register the substance. However, according to Article 8(1) of the REACH Regulation manufacturers of substances, formulators of mixtures or producers of articles established outside the EEA, can nominate an only representative established within the EEA to carry out the required registration. This will relieve the individual EEA importers within the supply chain of that non-EEA manufacturer from their registration obligations for these substances. They will be regarded as downstream users of this only representative. However, the registration obligation may still apply if the EEA-importers import the same substance from other non-EEA manufacturers.
 
More information on the only representative role can be found in Only Representative of non-EU manufacturer and in section 2.1.2.5-'Only representative of a "non-EU manufacturer"' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach.
What are the options for an importer of a mixture when he is unable to obtain the relevant information from his supplier on the components of the mixture?
To fulfil his duties as a registrant an EEA-based importer of mixtures has to have information on the composition of the mixtures he imports into the EEA. This obligation already existed under the previous legislation as regards substances to be classified as dangerous. Under REACH, an importer needs to know at least the identity and percentage content of all substances in the mixtures he imports that could exceed the amount of one tonne/year.
 
If the non-EEA supplier is not willing or not able to provide the required information, the importer has the following options:
- identify the formulator of the mixture (if different from the supplier) and ask him directly for the required information,
- propose to the non-EEA formulator that he appoints an only representative in accordance with Article 8 of the REACH Regulation,
- establish the composition of the mixture by analytical means,
- find an alternative supplier who is prepared to provide all required information for the mixture.
Can a third party representative register?

No, under REACH, a third party representative cannot register. A third party representative can be appointed by a manufacturer, importer or downstream user for data sharing issues and discussions with other manufacturers, importers or, where relevant, downstream users. Unlike an only representative, a third party representative only plays a part in the negotiations between the (potential) registrants, while the appointing company remains responsible for complying with its registration obligations.

A company who notified a substance under Directive 67/548/EEC fails to claim its registration number for the notified substance. Is this substance still considered as registered? If this is the case and an inquiry is subsequently submitted for this substance by a potential registrant can this notifier be listed as the registrant?
In accordance with Article 24 of the REACH Regulation, ECHA assigns a registration number to each notification submitted under Directive 67/548/EEC and the substance is considered registered according to REACH. The owner of the notification needs to claim the registration number from ECHA via REACH-IT in order to have valid evidence of a registration for the previously notified substance.

If an inquiry for this substance is submitted to ECHA by a potential registrant, the contact details of the notifier are communicated to the potential registrant according to Article 26(3) of REACH. In this respect, claimed and non-claimed registration numbers are treated equally in REACH-IT.

A letter with contact details of the potential registrant will also be sent to the notifier. In the same letter ECHA will again remind the notifier to claim the registration number.
What are the duties of registrants that cease manufacture and import?
If a registration for a substance has been submitted, the obligations to update the registration (Article 22) and to keep information (Article 36) apply. This means that a registrant ceasing manufacture and import of this substance has to inform the Agency about the new total tonnage manufactured and imported (in this case zero t/a). Furthermore this registrant has to keep available all the information he required to carry out his duties under REACH for a period of at least 10 years after he last manufactured, imported, supplied or used the substance (as such or in a mixture). In this regard, the period of at least 10 years does not start if the registrant, who ceased manufacture and import, still supplies or uses the substance.
If I have already notified a substance under Directive 67/548/EEC, what do I have to do if I increase my tonnages?

Under REACH, substances notified in accordance with Directive 67/548/EEC (known as NONS: Notification of New Substances) are regarded as registered by the manufacturer, importer, or sole representative who submitted the notification. You, as owner of the notification, can claim a registration number from ECHA for the tonnage notified. For practical details please see the Questions and Answers on NONS:

http://echa.europa.eu/support/qas-support/qas.

If the quantity of the manufactured or imported substance which you have notified reaches the next tonnage threshold, (1, 10, 100 or 1000 tonnes/year), you need to update your registration without 'undue delay'. You do not need to stop your manufacturing/importing while your updated dossier is processed unless otherwise indicated by ECHA.

When updating your registration dossier you need to comply both with:

  • the information requirements of the new tonnage band; and
  • the information requirements from the lower tonnage bands.

For example, if you increase your tonnage to 10 tonnes/year or more, you need to submit the information required for 10 tonnes or more (Annex VIII), the chemical safety report; and also the information required for 1 tonnes or more (Annex VII).

In order to avoid unnecessary testing on vertebrate animals, you have to inform ECHA immediately of the additional information requirements for the new tonnage level by submitting an inquiry dossier. Upon receipt of this information, ECHA acts as in the inquiry process which is further described in the chapter 'Update of registration dossier for substances regarded as being registered under REACH' of the Guidance on registration: http://echa.europa.eu/guidance-documents/guidance-on-reach. ECHA should inform you of the names and addresses of the previous registrants and of any relevant study summaries already submitted by them in order to share existing data and to ensure that studies on vertebrate animals are not unnecessarily repeated.

Does the phrase "classified as [...] in accordance with Directive 67/548/EEC" in Article 23(1)(a) and (b) of the REACH Regulation refer only to substances listed with a harmonized classification in Annex I of this directive?
The wording of Article 23(1)(a) and (b) of the REACH Regulation "classified as [...] in accordance with Directive 67/548/EEC" refers to both, substances listed in Annex I with their harmonised classification and to self-classified substances.
 
It may be inferred from Articles 4 and 6 of Directive 67/548/EEC that substances shall be classified (by manufacturers/importers) according to the criteria in Annex VI of that Directive. In addition, Annex I of that Directive contains the list of substances classified by the Commission, following discussions in expert groups. As the Directive covers both situations, substances should therefore be considered as classified in accordance with Directive 67/548 not only when listed with their harmonised classification in Annex I, but as soon as they meet the criteria for classification set out in Annex VI of that Directive, i.e. also when self-classified by the registrant, should the substance not (yet) be listed in Annex I. Both situations should be considered as "classification in accordance with Directive 67/548/EEC".
 
This interpretation is borne out by the very spirit of REACH and in particular the aim and objective of the deadlines provided for in Article 23 of REACH. The aim of the earlier deadline for registration of substances with properties of very high concern is to gather earlier the necessary information on the substances, on their uses and for industry to develop and recommend appropriate risk management measures. Given the specific health and/or environmental concerns in this case the objective was not to defer the application of the REACH provisions for further years. To this end, the aim of the legislature in setting the earlier registration deadlines was clearly to cover both cases, as there is no difference in the protected public interest. Substances with non-harmonized classification are equally a ground for the same concern as substances with harmonised classification.
 
A consequence of this interpretation is that, as from 1 December 2010, as soon as a manufacturer or importer obtains evidence that his substance fulfils the classification criteria set out in Art. 23(1)(a) or (b) of REACH after that date, he will be obliged to register that substance immediately.
Does a registration of an isolated intermediate pursuant to Article 17(2) or Article 18(2) of REACH have to be updated due to a change of tonnage band?
A manufacturer or importer who has registered an isolated intermediate pursuant to Article 17(2) or Article 18(2) of REACH does in general not have to update this registration in case of a change of tonnage band. However, such a registration would have to be updated due to a change of tonnage band in two cases.
 
Case 1: Where the registration is for a transported isolated intermediate and the 1000 t/a threshold is reached, the registrant must update his registration dossier by submitting the information specified in Annex VII of the REACH Regulation, if not already included in the dossier.
 
Case 2: Where the registrant ceases manufacture and import of the isolated intermediate, he has the duties described in FAQ ID=54, which include an update of the registration.
I plan to manufacture/import a phase-in substance for the first time either less than 12 months before the relevant registration deadline or after it. When do I have to register this substance in each case?
The "no data, no market" principle set out in Article 5 of the REACH Regulation applies to all substances that are manufactured or imported in quantities of 1 t/a or more where they have not been registered or pre-registered. This means that a company planning to start manufacture or import of 1 t/a or more of a phase-in substance after the relevant registration deadline given in Article 23 of REACH needs to have validly registered the substance before starting this activity.
 
According to Article 28(6) of REACH a first-time manufacturer or importer of a substance may submit a late pre-registration within 6 months of the date of first manufacture or import in quantities of 1 t/a or more of that substance and no later than 12 months before the relevant registration deadline given in Article 23 of REACH. Therefore, a company planning to start manufacture or import of 1 t/a or more of a phase-in substance less than 12 months before the relevant registration deadline also needs to have validly registered the substance before starting this activity.
 
In both cases, prior to registration the company planning to start manufacture or import has to submit an inquiry according to Article 26 of REACH. Further information can be found in section 4.4- 'Substances subject to the inquiry process' of the Guidance on data sharing: http://echa.europa.eu/guidance-documents/guidance-on-reach
 
After the submission of the registration dossier it may take up to three weeks before ECHA informs the registrant whether his registration is complete or not. Manufacture or import of a substance cannot start before the end of this period and can only start once ECHA has informed the registrant that the registration is complete and a registration number has been assigned.
Are registration numbers assigned to active substances in biocidal products? Does ECHA disseminate any information on those substances?
REACH does not provide for the assignation of registration numbers to active substances in biocidal products. It is reminded that registration numbers are assigned exclusively for substances:
- where complete registration dossiers were submitted to ECHA by the registrant according to Article 20 of REACH;
- which were notified under Directive 67/548/EEC and the registration number was claimed by the notifier according to Article 24 of REACH.
 
Regarding the information on active substances in biocidal products, this is held by the European Commission, and certain information is publicly available via its website at http://ec.europa.eu/environment/biocides.
 
ECHA has access to the information necessary for data sharing purposes.
If a registrant decides to change its Third Party Representative (TPR) does it need to update the registration and is there a fee for this?

If a registrant changes its TPR, the new TPR will have to create a REACH-IT account (provided he does not yet have a REACH-IT account).

In case of a change of TPR, the following steps shall be taken by the registrant in order to update the details of its TPR:

To update a TPR in a pre-registration or a registration submission: Go to menu -> Search -> Reference numbers -> Input the number in the search criteria -> Click on the results -> Click on Edit under Third party representative -> Add the new TPR.

No fee is required if the TPR is updated in a registration dossier.

I am a potential registrant of a non-phase-in substance or phase-in substances that has not been pre-registered. I am already in contact with the Lead Registrant (LR). Do I still need to send an inquiry to ECHA?

Yes. You have to submit an inquiry to ECHA although you have established a contact with the lead registrant (LR) and therefore have access to the respective and most up to date data package.

The obligation to submit an inquiry serves to avoid unnecessary testing and in particular to reduce testing on vertebrate animals. In addition, it provides the potential registrants the advantage that ECHA has verified the identity of the substance foreseen for registration and puts them in contact with the correct previous registrants and inquirers. By contrast, it is up to the members of a SIEF themselves to verify that they register the same substance.

Further guidance can be found in the Questions and Answers documents on inquiry and substance identification available in the following web page:
http://echa.europa.eu/regulations/reach/substance-registration/inquiry

Who can benefit from the phase-in scheme?

Manufacturers and importers who have manufactured a substance in any of the current Member States of the EU at least once after 31 May 1992 (15 years before the entry into force of REACH) and never placed it on the EU market can benefit from the phase-in scheme. This benefit also applies if you were a manufacturer before the entry into force of REACH and became an importer after it.

For all other manufacturers and first time importers who did not manufacture the substance in the EU, the substance is considered as a non-phase-in substance.
 

I would like to cooperate with a company in another Member State by ‘chemical leasing'. Does this business model influence my registration obligations under REACH?
Business models such as ‘chemical leasing', where the purchase is based on the fulfilled functions performed by the chemical and where the value-based units, such as the number of painted articles, are the main basis for payment, or any other business models do not influence your registration obligations. 
 
It is still the manufacturer or the importer to the EU who is responsible for registering the relevant substances under REACH.
A phase-in substance was registered and manufactured on an ongoing basis in the tonnage range 1-10 t/a. What does the registrant need to do, if they reach a higher tonnage threshold?

A registrant needs to update their registration without undue delay as soon as the ‘annual or total quantities’ they manufacture or import reach the next tonnage band threshold, as required by Article 22(1)(c). As soon as the annual volume of a substance that has already been registered (regardless of its phase-in status before registration) reaches the next tonnage threshold, the manufacturer or importer has the duty to immediately inform ECHA of the additional data required, following Article 12(2).

Further information is available at: http://echa.europa.eu/support/registration/your-registration-obligations/do-i-reach-the-one-tonne-a-year-threshold

Chi è il dichiarante in caso di fabbricazione su commissione di sostanze?

Con l’espressione «fabbricante per conto terzi» si intende solitamente un’azienda che fabbrica una sostanza (sostanza in quanto tale o in quanto componente di miscele o di articoli) presso i propri impianti, seguendo le istruzioni di un terzo in cambio di un compenso economico. Tale sostanza viene generalmente immessa sul mercato dal terzo. Questa struttura viene utilizzata, ad esempio, nel processo di produzione quando si ha una fase intermedia per la quale sono necessarie apparecchiature sofisticate (distillazione, centrifuga, ecc.). Ai sensi del regolamento REACH, i fabbricanti di sostanze sono tenuti a registrare le sostanze che fabbricano in quantità superiori a una tonnellata all’anno. In quest’ottica, il fabbricante per conto terzi è un fabbricante e deve registrare la sostanza.

Questo scenario è ulteriormente discusso nella scheda informativa «Il fabbricante su commissione a norma del regolamento REACH» disponibile al seguente link:
http://echa.europa.eu/documents/10162/13634/factsheet_toll_manufacturer_it.pdf

Si devono registrare le sostanze intermedie?

Ciò dipende dal tipo di sostanza intermedia, così come descritto ai sensi dell’articolo 3, paragrafo 15, del regolamento REACH, nella quale rientra la sostanza intermedia in questione, indipendentemente dal fatto che si sia soggetti a obblighi di registrazione o meno.

  • Sostanze intermedie non isolate:

Per usare una sostanza come sostanza intermedia non isolata non vi sono obblighi specifici ai sensi del regolamento REACH.

  • Sostanze intermedie isolate in sito:

Un fabbricante di sostanze intermedie isolate in sito in quantitativi pari o superiori a 1 tonnellata all’anno deve registrare le sue sostanze (se non è esentato dalla registrazione per altri motivi) (cfr. FAQ ID=30). Tuttavia, i dichiaranti di sostanze intermedie isolate in sito possono fornire informazioni di registrazione ridotte a norma dell’articolo 17, paragrafo 2, del regolamento REACH se confermano che la sostanza è fabbricata e usata in condizioni rigidamente controllate come descritto nell’articolo 17, paragrafo 3 del REACH.

  • Sostanze intermedie isolate trasportate:

I fabbricanti o gli importatori di sostanze intermedie isolate trasportate in quantitativi pari o superiori a 1 tonnellata all’anno devono registrare le loro sostanze (se non sono esentati dalla registrazione per altri motivi). Tuttavia, un dichiarante di sostanze intermedie isolate trasportate può fornire informazioni di registrazione ridotte a norma dell’articolo 18, paragrafo 2, del regolamento REACH, qualora confermi di produrre e/o utilizzare la sostanza in condizioni rigidamente controllate e qualora confermi o dichiari di avere ricevuto conferma da parte dell’utente che la sostanza è utilizzata in condizioni rigidamente controllate, come descritto ai sensi dell’articolo 18, paragrafo 4, del regolamento REACH. In questo caso, sia il dichiarante che gli utilizzatori sono responsabili delle proprie dichiarazioni relative alle condizioni rigidamente controllate.
Quando e come si possano utilizzare le disposizioni specifiche per la registrazione delle sostanze intermedie ai sensi del REACH è descritto nella Guida alle sostanze intermedie: http://echa.europa.eu/it/guidance-documents/guidance-on-reach.

Maggiori informazioni sono consultabili all’indirizzo: https://echa.europa.eu/documents/10162/13655/pg16_intermediate_registration_it.pdf
 

Cosa rientra nella definizione di PPORD (attività di ricerca e sviluppo orientata ai prodotti e ai processi)?
Ai sensi dell’articolo 3, paragrafo 22, del regolamento REACH, per attività di ricerca e sviluppo orientata ai prodotti e ai processi si intende «qualsiasi attività scientifica connessa allo sviluppo di un prodotto o all’ulteriore sviluppo di una sostanza in quanto tale o in quanto componente di preparati o articoli, nel corso della quale si utilizzano impianti pilota o produzioni sperimentali per mettere a punto il processo di produzione e/o sperimentare i campi d’applicazione della sostanza». Qualsiasi sviluppo scientifico di una sostanza consistente, ad esempio, in campagne per l’aumento di scala o il miglioramento di un processo di produzione in un impianto pilota o nella produzione a pieno regime o nell’indagine dei campi di applicazione per tale sostanza rientra nella definizione di PPORD. Ciò si applica indipendentemente dal tonnellaggio coinvolto.
Per promuovere l’innovazione, l’articolo 9 del regolamento REACH specifica che le sostanze fabbricate o importate in quanto tali o in quanto componenti di una miscela, oltre che le sostanze incorporate in articoli o importante in articoli a fini di attività di ricerca e sviluppo orientata ai prodotti e ai processi possono essere escluse dall’obbligo di registrazione per un periodo di 5 anni. Per usufruire dell’esenzione un’impresa deve trasmettere all’ECHA una notifica PPORD. Su richiesta l’ECHA può prorogare ulteriormente l’esenzione per un periodo della durata massima di 5 anni o, nel caso di sostanze destinate a essere utilizzate esclusivamente nella messa a punto di medicinali (per uso umano o veterinario), o di sostanze che non sono immesse sul mercato, per un periodo della durata massima di 10 anni. Ulteriori informazioni sono disponibili negli Orientamenti su ricerca e sviluppo scientifici (SR&D) e attività di ricerca e sviluppo orientate ai prodotti e ai processi (PPORD): http://echa.europa.eu/it/guidance-documents/guidance-on-reach.
How can a registration dossier be corrected in case a mistake was made in the preparation of the dossier?
After you have submitted your registration dossier to ECHA you may realise that you made a mistake during its preparation. This might be the case, for example, if you accidentally introduced faulty information in the dossier (e.g. incorrect information in one of the study summaries) and noticed this only after you submitted the dossier to ECHA. In this case you should without undue delay submit the amended dossier as a spontaneous dossier update via REACH-IT, indicating in the dossier header the reason(s) why you are spontaneously updating it as well as the references of the previous valid submission (i.e. the "last submission number"). Such an update would not be subject to a fee, unless the mistake is related to a chargeable element such as an increase in tonnage band, or confidentiality claims for information listed in Article 119(2).
 
Some mistakes may prevent a successful submission of the dossier to ECHA. These are failures in the business rules or the completeness check. If your submission fails either of these checks, you will be alerted to the failure in the form of a task in REACH-IT, which prompts you to amend the dossier. For more information on these topics, please refer to the following Q&A entries:
 
What should I do if there is no SIEF Formation Facilitator (SFF) in my pre-SIEF?

The SFF role was created to initiate and conduct discussions after pre-registration, and to facilitate the exchange of information and data required to form the SIEF. However, the SFF role is not formally recognised under REACH and potential registrants have no legal obligation to use an SFF to form a SIEF. If no pre-SIEF member has taken the initiative to take on the role of SFF or the SFF is inactive, you should contact the other pre-SIEF members to know more about the status of your SIEF.

The pre-SIEF is the first step for recognising potential registrants of the same substance and help you to start discussions on substance identity and substance sameness. SIEFs are expected to start communicating and organising themselves outside the REACH-IT environment. ECHA recommends that potential registrants contact their relevant trade associations to receive further advice on how to evolve from pre-SIEFs to SIEFs.

Do chromic acids and their oligomers, generated in water from chromium trioxide, require their own registration under REACH?

When brought in contact with water, chromium trioxide (EC number 215-607-8) forms two acids and several oligomers: Chromic acid (EC number 231-801-5), Dichromic acid (EC number 236-881-5), Oligomers of chromic acid and dichromic acid.

These chemical species are identified as substances of very high concern (SVHC) and included in the Candidate List1 as two separate entries.

Chromic acids and their oligomers generated in water from chromium trioxide are commonly referred to as an aqueous solution of chromium trioxide. With regard to the obligation to register, it may be justifiable in some specific situations described in the table below, to consider for practical reasons chromic acids and their oligomers as an aqueous solution of chromium trioxide. Hence, in these specific cases, chromic acids and their oligomers present in an aqueous solution of chromium trioxide can be covered by a registration dossier for chromium trioxide.

Important note: The presented approach is strictly limited to chromium trioxide and chromic acids and their oligomers generated from chromium trioxide in water. It derives from very specific aspects of the Chromium VI aqueous chemistry; the system in aqueous solution is a complex equilibrium between multiple chemical species which depends on several physico-chemical parameters and the different chemical species cannot be isolated from the aqueous solution. The approach can thus not be applied by analogy to any other substance.

Manufacturers and importers of chromium trioxide and chromic acids and their oligomers have to consider the following situations:

 

Actor / Scenario Legal requirement Explanation
Manufacturer or importer of chromium trioxide who generates chromic acids and their oligomers in water One registration according to Article 10 for chromium trioxide

The generation of chromic acids and their oligomers by adding chromium trioxide to water and their further use have to be included in the registration dossier and have to be considered for the chemical safety assessment (CSA) and the chemical safety report (CSR).

In case a downstream user (DU) generates chromic acids and their oligomers from chromium trioxide, this use has to be communicated up the supply chain and has to be included in the registration dossier.

Importer of both chromium trioxide and chromic acids and their oligomers generated in water from chromium trioxide

One registration according to Article 10 for chromium trioxide The registrant has to register chromium trioxide and chromic acids and their oligomers in one dossier for chromium trioxide. It has to become clear from the registration dossier that chromic acids and their oligomers are also imported. Therefore, at least two compositions have to be provided in section 1.2 of the IUCLID dossier. The first composition refers to chromium trioxide; the second composition refers to the composition of chromic acids and their oligomers. A remark has to be entered to clarify the approach.  The tonnage to be reported is the aggregated tonnage of both chromium trioxide and chromic acids and their oligomers. The tonnage has to be reported on the basis of equivalent chromium trioxide tonnage. 
Importer of chromic acids and their oligomers generated in water from chromium trioxide Registration according to Article 10
either for chromic acids and their oligomers generated from chromium trioxide
or for chromium trioxide

In case the importer decides to register chromic acids and their oligomers in a dossier for chromium trioxide, it has to become clear from the registration dossier that what is actual imported are chromic acids and their oligomers.

Therefore at least two compositions have to be provided in section 1.2 of the IUCLID dossier. The first composition refers to the generic substance "chromium trioxide"; its purity and composition should be indicated as 100 %. The second composition shall refer to the actual composition of chromic acids and their oligomers which are imported. A remark has to be entered to clarify the approach.  
Manufacturer or importer of chromic acids and their oligomers generated by alternative methods other than from adding chromium trioxide to water
or
Importer who is unaware of the manufacturing methods of the chromic acids and their oligomers
Registration according to Article 10 for chromic acids and their oligomers The approaches described above cannot be applied as the starting material for manufacturing chromic acids and their oligomers is not chromium trioxide or is not known. 

 

Please, also see Q&A=805 (Can an application for authorisation for chromium trioxide cover the use of the chromic acids and their oligomers generated from adding chromium trioxide to water?)

How do I register if I am located outside the EEA?
What are some examples of manufacturing?

Under REACH, manufacturing means producing or extracting substances in their natural state. It is a case-by-case decision to establish the extent to which the different steps in producing the substance are covered by the definition ‘manufacturing'.

Example
A company that purchases registered substances from within the EU and then formulates these into mixtures (e.g. paints) would be regarded as a downstream user under REACH.

In layman's terms, this company might be considered to be a manufacturer of paints. However, within the context of REACH, the company would not be a manufacturer of a substance and so would have no registration obligations for these substances. For further information see the Guidance on registration (http://echa.europa.eu/documents/10162/13632/registration_en.pdf). Examples on manufacturing on intermediates available in the Guidance on intermediates and Practical Guide 16.

Come si determina chi è responsabile per l’importazione?

È necessario registrarsi se si è l’entità giuridica stabilita nell’UE responsabile per l’importazione.

La responsabilità per l’importazione dipende da molti fattori, quali:

  • chi ordina?
  • chi paga?
  • chi si occupa delle formalità doganali?
    Tuttavia, questo potrebbe non essere determinante di per sé.

Esempio
Un’agenzia di vendite stabilita nell’UE agisce come intermediario, vale a dire trasmette ordini dagli acquirenti ai fornitori non appartenenti all’UE (ed è pagata per questo servizio). Tuttavia, tale agenzia non si assume alcuna responsabilità in merito alle merci o al pagamento delle merci e non è proprietaria delle merci in nessuna fase del processo. In questo caso, l’agenzia di vendite non è considerata essere un importatore ai fini del regolamento REACH. L’agenzia di vendite non è responsabile dell’introduzione fisica delle merci.

In molti casi, anche se non in tutti, l’ultimo a ricevere le merci (il destinatario) sarà l’entità giuridica responsabile dell’importazione delle merci.

Per ulteriori informazioni ed esempi cfr. capitolo 2.1.2.4 «Chi è responsabile della registrazione in caso di importazione?» della Guida alla registrazione:

Come documento il fatto che i miei fornitori hanno nominato un rappresentante esclusivo?

Se i fornitori sono stabiliti al di fuori dell’UE e decidono di nominare un rappresentante esclusivo sono tenuti a confermare tale evenienza a tutti gli importatori. Sarebbe preferibile ottenere anche conferma scritta da parte del rappresentante esclusivo del fatto che il tonnellaggio importato e l’uso sono in effetti coperti dal fascicolo di registrazione.

Ciò non consente soltanto di avere un punto di contatto presso il quale si può rendere noto il proprio uso della sostanza, ma serve anche a documentare in maniera chiara che le importazioni sono in effetti coperte dalla registrazione del rappresentante esclusivo.

È necessario conservare documenti precisi che indichino quali quantità importate della sostanza sono coperte dalla registrazione del rappresentante esclusivo e quali quantità non lo siano. Per ulteriori informazioni, si veda il capitolo 2.1.2.5 «Rappresentante esclusivo di un “fabbricante non appartenente all’UE”» della Guida alla registrazione:

Come si documenta la reimportazione di una sostanza registrata?

Le sostanze che sono state registrate, esportate e in seguito reimportate sono esenti dall’obbligo di registrazione a condizioni particolari.

Per beneficiare di questa esenzione, è necessario documentare che le seguenti condizioni siano soddisfatte:

  1. la sostanza dev’essere stata registrata prima di essere stata esportata dall’UE;
  2. la sostanza già registrata ed esportata deve essere uguale alla sostanza che si sta reimportando;
  3. la sostanza non solo deve essere la stessa ma deve effettivamente provenire dalla medesima catena di approvvigionamento in cui la sostanza è stata registrata;
  4. il reimportatore deve aver ricevuto informazioni concernenti la sostanza esportata come richiesto dal regolamento REACH (ad esempio, scheda di dati di sicurezza).

Per ulteriori informazioni, cfr. capitolo 2.2.3.6 «Sostanze reimportate» della Guida alla registrazione:

Come si documentano le sostanze sottoposte a controllo doganale?

Se le sostanze sono in deposito temporaneo in vista di una riesportazione e rimangono sotto controllo doganale, non sono soggette al regolamento REACH.

Per sfruttare questa esenzione, è necessario documentare che le seguenti condizioni siano soddisfatte:

  1. le sostanze vengono collocate in zone franche o in depositi franchi come prescritto dalla legislazione doganale o sottoposte ad altra procedura doganale pertinente (procedura di transito, deposito temporaneo);
  2. le sostanze sono sottoposte al controllo delle autorità doganali;
  3. le sostanze non vengono sottoposte ad alcuna forma di trattamento o lavorazione durante la loro permanenza nell’UE. Una zona franca o un deposito franco nel territorio dell’Unione europea costituisce parte dell’UE.

Per ulteriori informazioni si veda il capitolo 2.2.2.2 «Sostanze sottoposte a controllo doganale» della Guida alla registrazione:

Quali sono alcuni esempi di articoli contenenti sostanze destinate a essere rilasciate?

Le sostanze possono essere destinate a essere rilasciate da articoli al fine di fornire «valore aggiunto». I giocattoli per bambini profumati, ad esempio, sono articoli fabbricati con l’intento di rilasciare sostanze. Il rilascio è una qualità aggiuntiva del giocattolo ed è pertanto intenzionale dato che conferisce valore aggiunto, vale a dire un odore gradevole.

Come contro-esempio, si consideri il caso di una cartuccia di stampante o un panno per pulire umido. In questi casi, le sostanze possono essere fisicamente separate dall’articolo. Pertanto, non possono essere considerate sostanze presenti all’interno dell’articolo, quanto piuttosto sostanze presenti in un contenitore.

Di conseguenza, il fornitore di cartucce è considerato essere un fornitore di sostanze e, pertanto, si applicano gli obblighi di registrazione generali.

Per ulteriori informazioni consultare gli Orientamenti sugli obblighi per le sostanze presenti negli articoli:

Come si può sapere se una sostanza in un articolo è stata registrata per un determinato uso?

Nella maggior parte dei casi, se si vogliono individuare gli usi per i quali una sostanza è stata registrata, occorre rivolgersi ad altri attori a monte della propria catena d’approvvigionamento.

A tale fine, è necessario descrivere la funzione della sostanza nell’articolo, il processo mediante il quale la sostanza viene inclusa negli articoli e in quale tipo di articolo. Tale descrizione dovrebbe essere in linea con il sistema dei descrittori degli usi.

Le schede di dati di sicurezza (SDS) possono essere utili dato che contengono informazioni su usi della sostanza o della miscela nella misura in cui questi sono noti al fornitore. Se una SDS riporta inoltre un numero di registrazione, è possibile, a seconda del livello di precisione delle descrizioni d’uso nella SDS, concludere che un uso particolare di questa sostanza è già stato registrato. Tuttavia, in caso di dubbio, si dovrebbe richiedere conferma al dichiarante attuale a monte della catena di approvvigionamento.

In alternativa, si possono individuare i fabbricanti o gli importatori di tale sostanza in qualsiasi catena d’approvvigionamento e chiedere loro gli usi per i quali hanno registrato tale sostanza, o se l’hanno registrata per un uso particolare.

Un buon metodo per individuare i fabbricanti e gli importatori di una sostanza è lanciare una richiesta ad hoc nel forum per lo scambio di informazioni sulle sostanze (SIEF), purché si sia preregistrata la sostanza o si faccia parte del SIEF in qualità di titolare di dati.

Per ulteriori informazioni consultare gli Orientamenti sugli obblighi per le sostanze presenti negli articoli:

Quali sono i doveri di un rappresentante esclusivo?

Un rappresentante esclusivo ha la piena responsabilità di ed è obbligato ad adempiere a tutti gli obblighi degli importatori per le sostanze di cui è responsabile. Tali obblighi e responsabilità riguardano non solo la registrazione ma anche tutti gli altri obblighi degli importatori ai sensi di REACH. In qualità di rappresentante esclusivo, si è tenuti a registrare le quantità importate a seconda degli accordi contrattuali con il «fabbricante non appartenente all’UE».

Il rappresentante esclusivo può rappresentare uno o più «fabbricanti non appartenenti all’UE». Se agisce per conto di più «fabbricanti non appartenenti all’UE», il rappresentante esclusivo deve presentare una registrazione separata per ciascuno di questi fabbricanti.

Il fascicolo di registrazione deve contenere tutti gli usi degli importatori oggetto di registrazione. Il rappresentante esclusivo dovrà tenere a disposizione una lista aggiornata degli importatori all’interno della medesima catena di approvvigionamento del «fabbricante non appartenente all’UE», ivi compresi il tonnellaggio pertinente a ciascuno di questi importatori e informazioni sulla comunicazione dell’ultimo aggiornamento della scheda di dati di sicurezza.

Per ulteriori informazioni, si veda il capitolo 2.1.2.5 «Rappresentante esclusivo di un “fabbricante non appartenente all’UE”» della Guida alla registrazione:

Cosa devo fare se mi rendo conto che il mio volume ha superato le 100 tonnellate all’anno?

Ogni anno, è necessario calcolare il tonnellaggio annuale come media dei tre anni precedenti.

Esempio

Se il volume annuo ammonta a 60 tonnellate nel 2013, 90 tonnellate nel 2014, 140 tonnellate nel 2015 e 200 tonnellate nel 2016, il tonnellaggio medio di tre anni nel 2016 è pari a 97 tonnellate all’anno; mentre nel 2017 è pari a 143 tonnellate.

In questo caso dovrete registrare la sostanza il prima possibile, poiché il termine di registrazione per le sostanze di volume superiore alle 100 tonnellate all’anno è scaduto il 31 maggio 2013. Le prescrizioni in materia di informazione devono essere basate sul tonnellaggio del 2017 calcolato come media del periodo 2014-2016, ossia 143 tonnellate.

Poiché il tonnellaggio annuo si basa su una media di tre anni, dovrebbe essere più semplice per le imprese prevedere un aumento del tonnellaggio annuale.

Per maggiori informazioni consultare la nuova Guida alla registrazione:

Qual è la definizione di polimero data nel regolamento REACH?

Un polimero è una sostanza le cui molecole sono caratterizzate dalla sequenza di uno o più tipi di unità monomeriche. Tali molecole devono essere distribuite su una gamma di pesi molecolari. Le differenze di peso molecolare sono attribuibili principalmente a differenze nel numero di unità monomeriche.

Conformemente a REACH, un polimero è una sostanza che soddisfa i seguenti criteri:

  1. più del 50 % del peso di tale sostanza consiste di molecole polimeriche contenenti almeno tre unità monomeriche aventi un legame covalente con almeno un’altra unità monomerica o un altro reagente; e
  2. la quantità di molecole polimeriche che presentano lo stesso peso molecolare devono essere meno del 50 % del peso della sostanza.

Per ulteriori informazioni cfr. il capitolo 2.2.3.7 «Polimeri» della Guida alla registrazione:

Per informazioni complete sui polimeri consultare gli Orientamenti sui monomeri e i polimeri:

Quali sono le sostanze incluse nell’allegato V?
L’allegato V del regolamento REACH elenca tredici ampie categorie di sostanze per le quali la registrazione è ritenuta inappropriata o superflua. L’esenzione dall’obbligo di registrazione si applica alle sostanze in quanto tali, purché queste soddisfino le condizioni necessarie all’esenzione fornite nella categoria specifica dell’allegato V.
 
Per informazioni più dettagliate su una qualsiasi categoria di sostanze è possibile consultare la Guida all’allegato V, che fornisce spiegazioni e informazioni di carattere generale per l’applicazione delle varie esenzioni e fornisce chiarimenti in merito a quando è possibile applicare un’esenzione e quando non è possibile.
 
Quali sostanze sono escluse dall’obbligo di registrazione nell’interesse della difesa?

In alcuni specifici casi il regolamento REACH autorizza i singoli Stati membri a escludere talune sostanze dall’obbligo di applicazione del regolamento, nell’interesse della difesa.

Maggiori informazioni sulle esenzioni nazionali nell’interesse della difesa nei singoli Stati membri sono disponibili sul sito web dell’Agenzia europea della difesa:

Qual è la definizione di sostanza intermedia non isolata data nel regolamento REACH?

Una sostanza intermedia non isolata è una sostanza intermedia che durante la sintesi non è intenzionalmente rimossa (tranne che per il prelievo di campioni) dalle apparecchiature in cui la sintesi ha luogo.

Per maggiori informazioni consultare la Guida alla registrazione:

Quali sostanze usate negli alimenti o nei mangimi per animali sono escluse dall’obbligo di registrazione?

Quando una sostanza viene impiegata in alimenti o in alimenti per animali conformemente al regolamento sulla sicurezza alimentare (CE) n. 178/2002, la sostanza non deve essere registrata.

Ciò vale anche per l’uso della sostanza:

  • come additivo alimentare in prodotti alimentari (direttiva 89/107/CEE del Consiglio);
  • come sostanze aromatizzanti in prodotti alimentari (direttiva 88/388/CEE del Consiglio e decisione 1999/217/CE della Commissione);
  • come additivo negli alimenti per animali (regolamento (CE) n. 1831/2003);
  • negli alimenti per animali (direttiva 82/471/CEE del Consiglio).

Quantitativi della stessa sostanza utilizzati per usi diversi da quelli correlati agli alimenti e ai mangimi non godono di tale esenzione. Soltanto le quantità della sostanza impiegate negli alimenti e negli alimenti per animali sono esenti dall’obbligo di registrazione a norma del regolamento REACH.

Per ulteriori informazioni cfr. il capitolo 2.2.3.1 della Guida alla registrazione:

Quali sostanze usate nei prodotti medicinali sono escluse dall’obbligo di registrazione?

Quando una sostanza viene impiegata in un prodotto medicinale che rientra nell’ambito d’applicazione:

  • del regolamento (CE) n. 726/2004 che istituisce procedure comunitarie per l’autorizzazione e la sorveglianza dei medicinali per uso umano e veterinario, e che istituisce l’Agenzia europea per i medicinali; oppure
  • della direttiva 2001/82/CE recante un codice comunitario relativo ai medicinali veterinari; oppure
  • della direttiva 2001/83/CE recante un codice comunitario relativo ai medicinali per uso umano, tale sostanza non deve essere registrata ai sensi del regolamento REACH per tale uso.

L’esenzione non prevede distinzioni tra principi attivi e non, in quanto viene applicata a qualsiasi sostanza «utilizzata nei medicinali». Gli eccipienti impiegati nei prodotti medicinali, pertanto, sono del pari esclusi dall’obbligo di registrazione.

Quantitativi della stessa sostanza utilizzati per usi diversi dall’impiego farmaceutico non godono di tale esenzione. Sono esenti dall’obbligo di registrazione solo i quantitativi di sostanza utilizzati nei medicinali.

Per ulteriori informazioni cfr. il capitolo 2.2.3.2 della Guida alla registrazione:

Quali sostanze usate nei biocidi sono considerate registrate?

Le sostanze attive fabbricate o importate per essere utilizzate esclusivamente in prodotti biocidi sono considerate registrate per gli usi a cui tale inclusione si riferisce nelle seguenti situazioni:

  • la sostanza attiva è stata approvata a norma del regolamento (UE) n. 528/2012 («BPR»); oppure
  • la sostanza attiva è in corso di revisione nell’ambito del programma di esame dei principi attivi esistenti istituito dall’articolo 16, paragrafo 2, della direttiva 98/8/CE e prorogato a norma dell’articolo 89 BPR.

L’elenco delle sostanze attive approvate è disponibile sul sito web dell’ECHA all’indirizzo:

Per verificare quali sostanze attive sono oggetto del programma di esame, si consiglia di consultare l’allegato II, parte I, al regolamento delegato della Commissione (UE) n. 1062/2014, disponibile anche sul sito web dell’ECHA:

http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/existing-active-substance

Un’esenzione dall’obbligo di registrazione ai sensi del regolamento REACH si applica anche nei seguenti casi:

  • la sostanza attiva è fabbricata o importata per l’uso in un biocida autorizzato conformemente alla procedura di autorizzazione semplificata (articolo 27 BPR);
  • la sostanza attiva è fabbricata o importata per l’uso in un biocida autorizzato conformemente alla procedura di autorizzazione provvisoria (articolo 55 BPR);
  • la sostanza attiva è fabbricata o importata esclusivamente per l’uso in un biocida interessato da esperimenti o test a fini di attività di ricerca e sviluppo scientifica o orientata ai prodotti e ai processi (articolo 56 BPR).

Se il dichiarante fabbrica o importa la sostanza per usi in prodotti biocidi e non, questi sarà tenuto a trasmettere una registrazione per i quantitativi della sostanza utilizzati nei prodotti non biocidi.

Quali sostanze usate nei prodotti fitosanitari sono considerate registrate?

Le sostanze attive fabbricate o importate per essere utilizzate nei prodotti fitosanitari, ai sensi del regolamento (CE) n. 1107/2009 relativo all’immissione sul mercato dei prodotti fitosanitari, sono considerate registrate a norma di REACH (per quell’uso specifico) se la sostanza attiva è approvata e inserita nel regolamento di esecuzione (UE) n. 540/2011 (elenco delle sostanze attive approvate) o se la domanda di approvazione della sostanza attiva è ammissibile a norma dell’articolo 9 del regolamento (CE) n. 1107/2009.

Quantitativi della stessa sostanza utilizzati per usi diversi da quelli nei prodotti fitosanitari non sono considerati come registrati anche se sono stati approvati. Non sono inoltre considerate registrate altre sostanze come i coformulanti, i sinergizzanti, gli antidoti agronomici e gli adiuvanti.

La Commissione tiene un elenco elettronico delle sostanze attive approvate (e non approvate), che è disponibile al seguente indirizzo:

http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=IT

Quando sarebbe opportuno registrare una sostanza recuperata?

Una sostanza recuperata dovrebbe essere registrata non appena non è più considerata un rifiuto (ossia quando soddisfa i criteri per la cessazione della qualifica di rifiuto).

Per ulteriori informazioni sui criteri per la cessazione della qualifica di rifiuto si rimanda al seguente indirizzo:

In che modo è possibile documentare il fatto che una sostanza recuperata è già registrata?

Per beneficiare di questa esenzione è necessario dimostrare che le seguenti condizioni sono state soddisfatte:

  1. la stessa sostanza deve essere stata registrata;
  2. la sostanza deve essere uguale;
  3. l’entità giuridica che si è occupata del recupero deve disporre delle informazioni prescritte dal REACH (per esempio, scheda di dati di sicurezza).

Per ulteriori informazioni, si rimanda al capitolo 2.2.3.5 «Sostanza recuperata già registrata» della Guida alla registrazione:

Quali sono le sostanze incluse nell’allegato IV?
L’allegato IV del regolamento REACH elenca un certo numero di sostanze per cui si ritiene siano disponibili informazioni sufficienti per considerare che presentano un rischio minimo per la salute dell’uomo e per l’ambiente.
 
Tali sostanze sono generalmente di origine naturale e l’elenco delle sostanze esentate dall’obbligo di registrazione comprende, ad esempio, l’acqua e l’azoto. Le sostanze incluse nell’allegato IV sono esenti dalle prescrizioni in materia di registrazione.
 
L’esenzione dall’obbligo di registrazione si applica alla sostanza in quanto tale, non a un uso particolare.
 
Per ulteriori informazioni si rimanda all’allegato IV del regolamento REACH
 
I pre-registered a substance which was not listed in the EINECS. In the list of pre-registered substances published by ECHA, a "list number" has been assigned to my substance. Should I report this list number in my registration dossier?

The list numbers published by ECHA are not official EC entries. However, we recommend you to assign such an entry to the phase-in substance you intend to register provided this list number is linked to a CAS number (list numbers starting with 6 or 8) or a chemical name (list numbers starting with 9) corresponding to a correct and specific identifier for your substance. If this entry is too generic for your substance and there is no appropriate EC entry available, you should not assign any list/EC number to your substance.

How do I proceed if I have concerns about confidential business information (CBI) when discussing substance sameness?

Consider taking specific measures in the SIEF to protect information that you consider CBI, but you nevertheless need to share with the SIEF to conclude on the substance sameness. You can, for example:

  1. Have confidentiality agreements that limit access to documents or other information to specific named persons, or departments; and
  2. Allow access to certain documents in a ‘reading room’ only (where copying is not allowed); and
  3. Agree to have certain documents reviewed and/or assessed only by a third party expert (independent consultant) or a trustee.

You can strengthen this by having additional personal confidentiality agreements for those who get access to the CBI documents. 

As a minimum, you should specify to the other SIEF members that the information is indeed CBI and, therefore, you communicate it and it can be used only for purposes of the verification of substance identity under REACH.

For more information on CBI, see section 9 of the Guidance on Data-sharing (https://echa.europa.eu/guidance-documents/guidance-on-reach).

I now have my registration number. What happens next?

Your registration dossier remains your responsibility. You need to keep it up to date.

If you need to give your customers safety data sheets, you will need to include your registration number in the safety data sheets the next time you update them. In addition, if you have conducted a chemical safety assessment and needed to develop exposure scenarios, you have to attach them to the safety data sheet, outlining the use-specific conditions of safe use of the substance. This needs to be done as soon as possible.

If you have claimed you are an SME and have benefited from the reduced registration fees, ECHA may verify the size of your company. Make sure that your REACH-IT account includes all the necessary documentation to justify the size of your company.

We strongly recommended that you discuss within your joint submission and your company to put a mechanism in place to update the registration dossier, if necessary. For example, you must also share data and give access to the joint submission to newcomers. You can charge for access to the data by sharing the costs in a fair, transparent and non-discriminatory way.

ECHA will check the compliance of at least 5 % of the received registration dossiers to verify that the information submitted is compliant with the legal requirements. The outcome of this dossier evaluation may be a request for additional information. Additionally, by 1 June 2022, ECHA will examine the testing proposals included in the dossiers.

Remember to keep a close eye on your REACH-IT account – we will communicate with you only through it.

Why have I not received a registration number even though I submitted my registration dossier on time?

There can be a number of reasons for this. Have a look at the scenarios below.

If you submitted your registration on time, you can continue to manufacture or import your substance even if you have not yet received your registration number. You would need to cease manufacture or import only if ECHA rejects your registration.

Your dossier is considered as ‘submitted’ when it passes the business rules step. You are informed about it through your REACH-IT account and ECHA then assigns a submission number and a submission date to your dossier. The proof that you have submitted a registration dossier is this submission number and submission date that you have received in your submission report in REACH-IT. If you are a lead registrant, it is only after your lead registrant dossier has passed the business rules check that the member registrants can submit their own dossiers.

If your dossier has failed the business rules check, you have also been informed about it through your REACH-IT account. In this case, you have missed the legal deadline and are not entitled to manufacture, import or market the substance in the EU/EEA. You can only start manufacturing or importing again once you have submitted a complete registration dossier and received a registration number from ECHA. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40). Submit a registration dossier as a matter of urgency! Document your submission attempts so that you can demonstrate that you took corrective action as soon as you could.

Scenario 1: ECHA is still processing your dossier

ECHA has until the end of August 2018 to verify the completeness of the dossiers that were submitted in April and May 2018. Keep track of the progress through your REACH-IT account. In the meantime, you can continue manufacturing or importing your substance.

Scenario 2: You have not paid the registration fee

Your registration will only be complete once ECHA has confirmed that your registration includes all the required information and you have paid the fee indicated in the invoice you have received through your REACH-IT account.

If you do not pay by the initial payment deadline indicated in the invoice, you will automatically be granted an extension. However, if you do not pay by this extended deadline, ECHA will reject your registration. You will have to cease manufacturing or importing activities, as you can only legally manufacture, import or market your substance once you have successfully registered it. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40).

Scenario 3: Your dossier has failed the first technical completeness check

In this scenario, we will tell you what needs to be done and what the deadline is for submitting the missing information. You will have at least four months for this, so invest time in fixing the errors reported before resubmitting the full information as an update. You only have this one last chance to update your dossier so that it passes the technical completeness check. Make sure that you follow the instructions carefully and provide all the information requested, and only resubmit when you are sure you have addressed all failures.

Use the Validation assistant tool in IUCLID to avoid the risk of failing again – you will not get a third chance. If you still have questions, contact ECHA to make sure you understand what you need to do to complete your dossier.

Scenario 4:  Your dossier has been rejected as it has failed the technical completeness check a second time

You will have to start the registration process all over again and resubmit your dossier as an initial submission. Any fee that you paid in connection with your failed first registration will not be refunded.

You will have to stop manufacturing or importing activities, as you can only legally manufacture, import or market your substance if you have successfully registered it. In the meantime, you may place on the market any stocks you might have (Reference: Q&A 40).

What should I do if I did not submit my registration dossier by 31 May 2018 deadline?

31 May 2018 was the last chance to submit a registration for existing (phase-in) substances manufactured or imported in amounts of more than one tonne per year. If the registration obligation applied to you, but you did not submit your dossier by then, as of 1 June you can no longer manufacture or import your substance legally in the EU/EEA. You may, however, continue placing on the market any stock that was manufactured/imported before the deadline.

If you missed the deadline, you should make yourself compliant without delay:

  • If you have pre-registered or inquired about your phase-in substance, you can register it directly (until further notice, you can still use the pre-registration number).
  • If you have not pre-registered or inquired about your phase-in substance, you need to submit an inquiry before registering it.

If you submit your dossier after 31 May, you will need to wait until you receive your registration number before resuming or starting manufacture or import of your substance.

 

What is the status of pre-registrations?

In principle, pre-registration numbers do not carry any meaning anymore. Substances manufactured or imported in quantities of more than one tonne per year in the EU/EEA must be registered unless they are exempt from the obligations under the REACH Regulation.

How do I know whether or not a substance has been registered?

Have a look at the lead registrant list, which is frequently updated. It shows the substances for which the registration process has been started and those to which a registration number has already been assigned. You can also check the list of registered substances on ECHA’s website. However, do note that not all registration dossiers have yet been published, as some are still being processed by ECHA.

You can see the names of registrants by viewing the information on ECHA’s website. The company names appear at the bottom of the ‘General Information’ section. However, in some cases, this may not include your specific supplier, such as when:

  • your supplier is not the one manufacturing or importing the substance; or
  • the registrant has successfully claimed the name as confidential or is an importer covered by a representative of the non-EU exporter.

The most reliable information should come from your supplier. Again, the longer the supply chain, the longer it will take for this confirmation to arrive to you.

My use is not covered by my supplier’s registration. What should I do?

You have several options, ranging from asking your supplier to include your use in their registration to preparing your own chemical safety report or adapting/stopping the use of the substance:

  1. Ask your supplier to include your use or conditions of use in their chemical safety report and to provide you with an exposure scenario for it. You need to make sufficient information available to your supplier to enable them to make such an assessment. Your sector organisation may have developed a convenient means of supplying this information specifically to your sector.
  2. Implement the conditions of use described in the exposure scenario you have received. This option may require changes to your processes or products.
  3. Eliminate the substance or activity or substitute it with a safer alternative.
  4. Find another supplier who can provide the substance with a safety data sheet and an exposure scenario covering your use.
  5. Carry out your own chemical safety assessment and prepare your own downstream user chemical safety report (DU CSR) for your uses and conditions of use, unless exemptions apply – see our practical guide How to prepare a downstream user chemical safety report for details. You will have to notify ECHA about this.

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Relazioni degli utilizzatori a valle

Downstream user report

What is the difference between a downstream user chemical safety report and a downstream user report?

A downstream user chemical safety report documents the results of the chemical safety assessment undertaken by the downstream user. The assessment establishes conditions to ensure that the risk for the use(s) not covered in the received exposure scenarios is adequately controlled. The downstream user chemical safety report itself does not need to be submitted to ECHA.

A downstream user report is a report by a DU to ECHA when:

  • He has to prepare a downstream user chemical safety report or is claiming exemption
  • His classification of the substance is different to that of his supplier
  • A downstream user notification is required when a downstream user uses a substance included in the Authorisation List, for which an authorisation has been granted that covers the use.
We are formulators. We routinely generate exposure scenarios for our mixtures to communicate to our customers. What are our legal obligations relating to the exposure scenarios?
When your customer use is not covered in the supplier exposure scenarios, and you decide to include it, you have to take action to ensure it is covered. The options include communicating with your supplier or preparing a downstream user chemical safety report.
 
If you prepare a chemical safety report, you have to provide the relevant exposure scenarios to the recipients (Article 31(7)).It might be the case that you generate exposure scenarios for your mixtures voluntarily. This could be for commercial reasons, or for better communication of the appropriate conditions of use. In such cases, the obligation to report to ECHA does not apply.
 
You need to ensure that the conditions of use in any exposure scenarios you generate are covered in the exposure scenarios you receive. To facilitate this process, you can provide your suppliers with generic exposure scenarios that you or your sector organisation have generated and provide to customers, and request that your supplier covers them.
I purchase chemicals from several suppliers. The classification of the same chemical is sometimes different from different suppliers. Do I need to report to ECHA under Article 38(4) of REACH?
Article 38(4) states that "a downstream user shall report to the Agency if his classification of a substance is different to that of his supplier". This is taken to refer to all of his suppliers.
You do not need to report to ECHA as long as your classification is the same as one or more of your suppliers. However, if you generate an entirely new classification, you shall report to ECHA. You are exempt from reporting to ECHA if you use the substance or mixture in a total quantity of less than one tonne per year, as per Article 38(5).
 
The reporting procedure is described in Question 17 below. Note that the requirement to report a new classification applies to all substances, registered and not registered.
If a downstream user, as part of his own chemical safety assessment, concludes that a study on vertebrate animals is needed to complete the assessment and makes a testing proposal, who conducts the study?

A downstream user can make a testing proposal. ECHA examines this proposal and decides on appropriate testing in accordance with Article 40 of REACH. It is the responsibility of the downstream user to perform the test, unless other downstream users or registrants are also interested in carrying out such a test.The interested parties can agree on who will perform the test on behalf of all of them. If agreement is not reached, the Agency shall designate one of the parties to perform the test on behalf of all. All parties concerned share the cost of the study.

Preparations of an IUCLID dossier for downstream user reports

Is it possible that a reference substance is not included in the reference substance inventory?

It is possible that a reference substance does not exist in the downloadable reference substance list. In this case, you will need to create the reference substance yourself. The reference substance needs to be included in the substance dataset. You can find more information on how to create a reference substance in section 6.1 of the manual How to prepare registration and PPORD dossier at: http://echa.europa.eu/manuals 

Why does a downstream user have to fill in Section 1.3 - Identifiers in IUCLID?

Downstream users have to provide all the information as required by Article 38 of the REACH Regulation.Section 1.3 of IUCLID is where you provide the supplier's registration number for the substance, as required by Article 38(2)(b). If the registration number is not available to you, you must provide a justification for this in the same section.

Additionally, when updating a downstream user report, you should also include in this section the downstream user report's reference number.

Therefore, it is advised to follow the instructions included in the Manual: How to prepare a downstream user report at: http://echa.europa.eu/manuals.

Submitting the downstream user report

How do I submit a downstream user report?
Two options are available for submitting a Downstream User report, (i) a Webform and (ii) via REACH-IT/IUCLID.
  • Option (i): The webform is the simpler option. It is recommended for most downstream users, especially those who have not used IUCLID before.
  • Option (ii): Reporting via REACH-IT is recommended for downstream users who already use IUCLID and want to maintain all their report records in the REACH-IT/IUCLID system.Downstream users who need to report if their classification is different to that of their supplier can only use option (ii), via REACH-IT.
A downstream user notification (when a downstream user uses a substance included in the Authorisation List, for which an authorisation has been granted that covers the use) can be submitted using a webform.
 
Downstream users should go to the web page on downstream user reports, and select the preferred reporting option:
 
 
What data has to be submitted in a downstream user report?
The information to be provided for unsupported uses (uses not covered in the supplier's extended safety data sheet) includes:
  • the identity and contact details of the downstream user;
  • the registration number of the substance, if available;
  • the identity of the substance;
  • the identity of the supplier;
  • a brief general description of the unsupported use(s) and conditions of use; and
  • a proposal for additional testing on vertebrate animals if this is considered necessary.
 
Note that a proposal for additional testing is not required for substances falling under the exemption of Article 37(4)(c) of REACH (< 1 tonne/year total use).
Is it possible to create one downstream user report for multiple substances, multiple uses, multiple legal entities or multiple sites?
A downstream user can only report on one substance per downstream user report. Nonetheless, a downstream user can include multiple uses and multiple sites, belonging to the same legal entity, in one report.
 
As a downstream user, you cannot submit a downstream user report on behalf of other legal entities or on behalf of a group of downstream users.
I need to report my new classification to ECHA according to Article 38(4) of REACH. How do I do this?
This reporting is done with IUCLID 6 and REACH-IT. Please take the following steps:
  1. Prepare a Downstream user report dossier in IUCLID 6 as explained in  the manual: How a downstream user report at: http://echa.europa.eu/manuals.
  2. In the IUCLID 6 dataset, enter information on your classification and labelling of the substance as explained in the manual How to prepare a classification and labelling notification at: http://echa.europa.eu/manuals
  3. Create the downstream user report dossier and export it as explained in the downstream user manual
  4. Submit the report to ECHA via REACH-IT

 

Is the submission of a downstream user report to the Agency subject to a fee?

No fee is charged for the submission of a downstream user report. ECHA fees and charges for services and their amounts are stated in the REACH Regulation and in Regulation (EC) No. 340/2008 (Fee Regulation).

How do I withdraw or amend my downstream user report?
If the report was submitted using the webform, it is necessary to submit a new downstream user report.
 
In the tab for "REASONS"/further information, please tick the box "other reasons" under the tick box "the use is not covered..". In that text box please enter "amending [report number]"or "withdrawing [report number]" as appropriate.
 
It is necessary for you to fill in the report again. However, if there is lengthy information, you can refer to your original report where the information is the same.
 
If the report was submitted via REACH-IT, submit an updated IUCLID dossier, indicating that the unsupported use previously reported has been amended or resolved.
Restrizioni

A. Domande di natura generale

Does the importer of a mixture have any obligations concerning potential impurities present in the mixture, where the impurity is a substance listed in Annex XVII?

The obligations of the importer of the mixture depend on the interpretation of each specific entry in Annex XVII to REACH for the substance concerned, taking account of the wording, the context and the purpose of the restriction in question.

For instance, if a substance were completely banned, then it could not be placed on the market, not even as an impurity in a substance in an imported mixture. On the other hand, some Annex XVII entries specify limits above which a substance cannot be placed on the market. This limit may not be exceeded, no matter what is the source of the substance in the mixture. However, this can only be determined on a case-by-case basis depending on the substance, the restriction and the concentration of the substance as an impurity in the imported mixture.

It should be noted that the impurity may be permissible at any concentration if the use of the imported mixture is not covered in the ‘conditions of restriction' listed in Annex XVII for the substance.

When a specific Annex XVII entry (e.g. entry 56 MDI) specifies the requirement for the package to contain protective gloves in order for the mixture to be placed on the market, is it possible to attach the protective gloves to the package, if it cannot contain them?

In special cases where, due to the size or shape of the packaging, it is technically not possible to include the protective gloves inside the packaging, it is considered to be sufficient that the gloves are fixed tightly to the packaging in a manner that they cannot be unintentionally removed during handling and transport. The gloves must not obstruct the label and the removal of the gloves must not destroy the label. In addition, both the packaging containing the mixture and the protective gloves must be placed on the market as a single unit, which explicitly signals to the consumer that the mixture may only be used with the protective gloves .

What is the definition of "toys", in the context of restrictions in Annex XVII to REACH?
A number of Annex XVII entries (Entries 5, 31, 43, 50 , 51 and 52) specifically refer to toys. The REACH Regulation does not  define "toys". Toys are defined by Directive 2009/48/EC (hereinafter referred to as the Toys Safety Directive-TSD).
 
Article 2(1) of the TSD states: "This directive shall apply to products designed or intended, whether or not exclusively, for use in play by children under 14 years of age (hereinafter referred to as toys)".
Annex I to the TSD contains a more detailed list of products that are not considered as toys within the meaning of the Directive. Article 3 of the TSD defines certain types of toys such as "functional toy", "aquatic toy", "chemical toy" and "activity toy". Furthermore, Article 2(2) of the TSD explicitly mentions that the TSD shall not apply to the following toys: (a) playground equipment intended for public use; (b) automatic playing machines, whether coin operated or not, intended for public use; (c) toy vehicles equipped with combustion engines; (d) toy steam engines; and (e) slings and catapults. It is considered that if the TSD definition of "toys" is used in Annex XVII to REACH, these exemptions will automatically form part of that definition.
 
The European Commission services have prepared an explanatory guidance document on the TSD, (http://ec.europa.eu/enterprise/sectors/toys/files/tsd-guidance/tsd_rev_1-6_explanatory_guidance_document_en.pdf) providing clarifications about its scope and definitions of certain categories of toys. Overall, the definition of toys in the TSD should be used to determine what we mean by "toys" for the purposes of restrictions in Annex XVII to REACH. Concerning toys exempted from the scope of the TSD (Article 2(2) of the TSD) these should also normally not be considered as "toys" for the purpose of the relevant REACH restrictions. In certain cases, it may be necessary to describe a class of toys to be covered by a restriction by reference to specific properties of the item.                                   
What is the definition of "childcare articles", in the context of restrictions in Annex XVII to REACH?
A definition of "childcare articles" was inserted by the 22nd amendment of Council Directive 76/769/EEC, (which was repealed by REACH, Annex XVII) via the Directive 2005/84/EC of the European Parliament and of the Council. Directive 76/769/EEC was amended so that the following definition for childcare articles was added in its Article 1(3)c: "childcare article" means any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children. Hence the intention of the legislator was to use this definition for the purpose of all the restriction provisions and thereby this to be applicable for the entire Directive 76/769/EEC. Therefore, the same definition appears in entries 51 and 52 of Annex XVII, providing an indication of what should be generally considered as a "childcare article" in the context of all Annex XVII (to REACH) provisions. 
 
What is the meaning of the expression "placing/placed on the market for the first time" in the context of entries 3(7), 31(2)(b), 58(1) and 59(1)(b) of Annex XVII to REACH?
Article 3(12) of REACH defines "placing on the market" as supplying or making available, whether in return for payment or free of charge, to a third party. Import is deemed to be placing on the market.
 
Placing on the market for the first time limits the scope of the restriction to the first natural or legal person who supplies or makes available substances, mixtures or articles on the market in the EU. The first placing on the market in the EU will either be by the manufacturer or the importer of the substance, mixture or article concerned.
 
In some cases a restriction entry in Annex XVII refers to specific Directives/Regulations when describing the inclusion or exception of some substances or product categories from the entry. If this Directive/Regulation is repealed or modified, is the new/amended legislation applicable to the restriction?
In general, the answer is yes. However, it should be assessed on a case-by-case basis whether the new legal act replaces the repealed one for the purpose of the REACH restriction, taking into account, for example, the objective of the reference. 
The new legal act may explicitly state that references to the repealed act must be construed as references to the new legal act (e.g., Article 139 of REACH).
For example:
  • Entry 19 (paragraph 4) exempts certain uses of arsenic compounds for wood preservation if they are authorised in accordance with Directive 98/8/EC. This Directive was replaced by Regulation (EU) 528/2012, which explicitly states that references to the repealed Directive must be interpreted as reference to the new regulation (Article 96).
  • Entry 45 (paragraph 3) exempts electrical and electronic equipment within the scope of Directive 2002/95/EC from the restriction of diphenylether, octabromo, derivative. This Directive was replaced by Directive 2011/65/EU, which explicitly states that references to the repealed Directive must be interpreted as reference to the new directive (Article 26).
  • Entry 50 (paragraph 3) defines tyres covered by the PAH restriction as tyres for vehicles covered by three directives, including Directive 2002/24/EC. This Directive was replaced by Regulation (EU) 168/2013, which expressly states that references to the repealed Directive must be interpreted as reference to the new regulation (Article 81).
As regards the amendment of an act referred to in a restriction, references in acts of Union law are usually ‘dynamic’, so that the reference is taken to be to the latest version of the act referred to. However, less commonly, a reference may expressly refer to an act as it stands on a specific date; this is known as a ‘static’ reference.
What information on restrictions is needed on the safety data sheet and when does the safety data sheet need to be updated due to restrictions?

Article 31(6) of the REACH Regulation provides that the safety data sheet (SDS) shall contain a Section 15 entitled ‘regulatory information’. Annex II to REACH provides requirements for the compilation of the SDS. Section 15(1) specifically mentions that, if the substance or mixture covered by the SDS is the subject of specific provisions in relation to the protection of human health or the environment at Union level (e.g. restrictions under Title VIII), these provisions must be mentioned, unless this information is already mentioned in other parts of the SDS. Thus, all restriction entries applicable to the specific substance or mixture covered by the SDS need to be indicated therein. As an example, SDSs including carcinogenic, mutagenic or toxic to reproduction substances (as such or in a mixture) listed in appendices 1 to 6 to REACH, need to refer to entries 28, 29 or 30 of Annex XVII. If another specific restriction exists for these substances, this needs to be mentioned as well in the SDS.

Moreover, Article 31(9) of the REACH Regulation requires suppliers to update the SDS without delay once a restriction has been imposed. In Section 16 (other information), a clear indication of where changes to the previous version have been made needs to be included, unless such indication is given elsewhere in the safety data sheet, with an explanation of the changes.

What is regarded as scientific research and development, which is exempted for restrictions? For example, does research by students at universities fall under this?
Article 3(23) of the REACH Regulation defines scientific research and development as “any scientific experimentation, analysis or chemical research carried out under controlled conditions in a volume less than one tonne per year”.
To further clarify the exemption (within Article 67(1) of the REACH Regulation, manufacture, placing on the market or use of a substance in scientific research and development (SRD) is exempted for restrictions), note that under the authorisation process the following Q&As (concerning the exemption in Article 56 for the use of Annex XIV substances in scientific research and development) has been provided. The same approach can be broadly considered as applicable to restrictions.
  • Q&A 1153 states that sampling for further analysis is not exempted and thus not regarded as scientific research and development. However, “activities considered to form part of the use of the sample in performing analytical activities” fall within the exemption. 
  • Q&A 1030 explains that the uses of a substance upstream preceding an exempted end-use in scientific research and development are also exempted in quantities of the substance ending up in SRD (i.e. under 1 t/y per user) subject to certain conditions. 
  • Q&A 585 explains that the exemption from authorisation also applies to the use of a substance in analytical activities such as monitoring and quality control under certain conditions. This exemption applies irrespective of where the analysis is performed i.e. on-site or off-site facilities, but does not cover sampling activities.
Scientific experimentation, analysis or chemical research in universities and secondary schools, conducted by students, may fall within the exemption, if they are carried out under controlled conditions, in a volume less than one tonne per year. In other words, if the volume of a substance used in scientific experimentation, analysis or chemical research is less than one tonne per year and it is used under controlled conditions, restrictions do not apply to that use. 
Which restrictions under REACH concern textiles and leather articles?

Many entries in the Restriction List (Annex XVII) cover articles. Such entries are, for instance, entries 50 - 52, 61 and 63. These may address types of textiles and leather articles, even if these are not explicitly mentioned.
The following entries in the Restriction List (Annex XVII) are specific to textiles: 
Entry 4 ((2,3 dibromopropyl) phosphate, CAS No 126-72-7);
Entry 7 (Tris(aziridinyl)phosphinoxide, CAS No 545-55-1; EC No 208-892-5) and 
Entry 8 (Polybromobiphenyls; Polybrominated biphenyls (PBB), CAS No 59536-65-1).
These entries state that these substances “Shall not be used in textile articles, such as garments, undergarments and linen, intended to come into contact with the skin.” 
The following entries in the Restriction List (Annex XVII) restrict substances in relation to textiles and/or leather articles:
Entry 18, restriction on mercury compounds in the impregnation of heavy-duty industrial textiles and yarn intended for their manufacture;
Entry 20 (paragraph 6), restriction on dioctyltin (DOT) compounds in textile articles intended to come into contact with the skin;
Entry 23 (paragraph 6), restriction on cadmium and its compounds in textiles and clothing; 
Entry 43, restriction on azocolourants and azodyes in textile and leather articles which may come into direct and prolonged contact with the human skin or oral cavity (indicative list is provided);
Entry 46 (paragraph 3) restriction on nonylphenol and nonylphenol ethoxylates in textiles and leather processing (with some exceptions);
Entry 46a, restriction on nonylphenol ethoxylates in textile articles which can reasonably be expected to be washed in water during their normal lifecycle, and
Entry 47 (paragraphs 5-7), restriction on chromium VI compounds in leather articles coming into contact with the skin.

Which restrictions under REACH concern electrical and electronic equipment?
Many entries in the Restriction List (Annex XVII) cover specific articles or all articles without explicitly referring to electrical and electronic equipment. These are, for example, entries 18a, 20, 23-26, 50-52. They may apply to electrical and electronic equipment, even if these are not explicitly mentioned (or derogated) in the entry.
The following entries of the Restriction List (Annex XVII) specifically include a derogation for electrical and electronic equipment: 
Entry 45 (paragraph 3) provides a derogation from the restriction on diphenylether, octabromo derivative (C12H2Br8O) for electrical and electronic equipment within the scope of Directive 2002/95/EC, which has been replaced by Directive 2011/65/EU (on the restriction of the use of certain hazardous substances in electrical and electronic equipment),  and
Entry 63 (paragraph 8) excludes articles within the scope of Directive 2011/65/EU from the restriction on lead and its compounds in articles supplied to the general public.
Which restrictions under REACH concern paints or paint strippers?
Many entries in the Restriction List (Annex XVII) cover substances and mixtures in general, without specifying product types. They may thus also apply to paints/paint strippers, even if these are not explicitly mentioned in the entry.
In addition, the following entries in the Restriction List (Annex XVII) explicitly restrict the placing on the market of paints and/or paint strippers: 
Entry 16, restriction on certain lead carbonates in substances or mixtures intended for use as paint;
Entry 17, restriction on certain lead sulphates in substances or mixtures intended for use as paint;
Entry 20, restriction of organostannic compounds acting as biocide in free association paint;
Entry 20 (paragraph 5), restriction on dibutyltin (DBT) compounds in paints and coatings; 
Entry 23 (paragraph 2), restriction on cadmium and its compounds in paints with codes [3208] and [3209] and in painted articles; 
Entries 28-30 (paragraph 1), restriction on CMRs as substances, as constituents of other substances or in mixtures (including paints), for supply to the general public; (paragraph 2) derogation for artists’ paints covered by Regulation (EC) No 1272/2008;
Entry 48, restriction on toluene (CAS No 108-88-3; EC No 203-625-9) in spray paints intended for supply to the general public; 
Entry 54, restriction on (2-(2-methoxyethoxy)ethanol (DEGME) (CAS No 111-77-3; EC No 203-906-6) for supply to the general public, as a constituent of paints and paint strippers;
Entry 55, restriction on 2-(2-butoxyethoxy)ethanol (DEGBE) (CAS No 112-34-5; EC No 203-961-6) for supply to the general public, as a constituent of paints and paint strippers and in spray paints and
Entry 59, restriction on dichloromethane in paint strippers under certain conditions.
In some cases a restriction entry (e.g. entries 32-38, 46) in Annex XVII refers to ‘cleaning’. What does this mean?

In general, cleaning refers to any removal of dirt or pollution from articles or places, both in industrial and institutional facilities as well as in households. 

In some entries cleaning may be specified by reference to a particular user group(s) or potential exposure pattern to which the restriction applies. For example, column 2, paragraph 1 of entries 32-38 refer to the substance or mixture being intended for supply to the general public and/or intended for diffusive applications where releases can occur from multiple sources such as surface cleaning and cleaning of fabrics. Column 2, paragraph 1 of entry 46 applies to industrial and institutional cleaning systems (e.g. in schools, hospitals), with the exception of dry cleaning done in a controlled closed system where the washing liquid is recycled or incinerated and other cleaning systems where special treatment is used with recycling or incineration of the washing liquid. Column 2, paragraph 2 entry 46 applies to all domestic cleaning.

Entry 03 of Annex XVII to REACH - Oil lamps

Which type of oil lamps are considered as decorative within the context of Entry 3 of Annex XVII?
An indicative description of "decorative oil lamps" is provided by the European Standard EN 14059 (which specifies requirements and test methods for decorative oil lamps) (section 3.6): 
Oil lamp for decorative purposes is an oil lamp for interior or exterior use (e.g. in garden torches) appealing by its design and or the light atmosphere it creates. 
 
In entry 3(1) what is included within the scope of ‘ornamental articles’, in addition to the examples of ornamental lamps and ashtrays in the legal text?
The restriction should be understood as a broad restriction covering all articles that contain liquids specified in the entry and intended to produce light or colour effects by means of different phases and which have an ornamental design. It does not matter if the article also has other functions besides being decorative. So for example, if articles such as cell phone covers, liquid timers, toothbrushes, shower curtains, key-rings and hourglasses contain ornamental features that produce light or colour effects, they are covered by the restriction even though the ornamental function is not the primary function of the article. Decorative LED lamps with glitter are also included within the scope of this restriction.
Entry 08 of Annex XVII to REACH - polybrominatedbiphenyls

What is the scope of entry 8 which concerns polybromobiphenyls and polybrominatedbiphenyls? A specific CAS number (59536-65-1) is referred to in the entry, but are other polybrominated biphenyls also included in the scope of this restriction?
All polybrominated biphenyls (also referred to as polybromobiphenyls) are covered by the restriction in entry 8. The CAS number referred to in entry 8 is only an example of one of the main commercially used fire retardant products at the time of the adoption of the restriction. 
Entry 16-17 of Annex XVII to REACH-lead compounds in paints

What is the definition of paints in the context of entries 16 and 17 of Annex XVII? In particular, are children's paint sets, and also other stationery-type paints such as artist paints and do-it-yourself (DIY) decorations for t-shirts also covered?

The REACH Regulation does not provide a specific definition for paints.
According to a general meaning, paint is a mixture, usually of a liquid with a solid pigment. Furthermore, Commission Decision 2009/544/EC (establishing the ecological criteria for the EU Ecolabel to indoor paints and varnishes) provides  the following definition: 'Paint' means a pigmented coating material, in liquid or in paste or powder form, which when applied to a substrate, forms an opaque film having protective, decorative or specific technical properties.
The abovementioned definitions provide an indication of what could be generally considered as a paint in the context of entries 16-17 of Annex XVII (to REACH) provisions.

It should be noted that the restrictions in entries 16-17 of Annex XVII only allow Member States to permit the use of paints containing the restricted substances for the restoration and maintenance of works of art and historic buildings and their interiors. Thus children's paint sets and other stationery-type paints such as artist paints and do-it-yourself (DIY) decorations for t-shirts must not contain the restricted substances.

Concerning children's paint sets, these may also be covered by the Toys Directive (Directive 2009/48/EC on the safety of Toys), which lays down limits for the presence of lead in toys.

Entry 18(a) of Annex XVII to REACH - Mercury

Are the repairing and maintenance activities covered by the restriction in Entry 18(a) of Annex XVII?
Fever thermometers and other measuring devices for sale to the general public in use in the European Union before the 3 April 2009: The prohibition concerns the placing on the market of fever thermometers and other measuring devices for sale to the general public after the 3 April 2009.
Pursuant to paragraph 2, thermometers as well as other measuring devices for sale to the general public in use in the European Union before the 3 April 2009 are exempted from the prohibition. These instruments containing mercury which were in use in the European Union before the 3 April 2009 can be placed on the second hand market except in the territories of Member States which decided to regulate theses existing instruments. Repairing and maintenance activities for these existing instruments are excluded from the scope of the restriction. Nevertheless, in the case of repairing and maintenance activities performed on these devices, new measuring devices containing mercury shall not be used as this would be considered making available new measuring devices to the general public.
How should derogation in entry 18(a) of Annex XVII related to Antique Barometers be interpreted?
Under 18(a) antiques measuring devices are defined as more than 50 years old on 3 October 2007.
Under paragraph 3 antique measuring devices are exempted from the restriction. Repairing and maintenance activities for these antique measuring devices are also exempted for the restriction.
The intention of the legislator in granting an exemption for antique measuring devices is that their trade should continue (Directive 2007/51/EC, Recital No 4) due to their cultural and/or historical value. Therefore these instruments should continue to be serviced in order to keep their cultural and/or historical value.
Antique measuring devices such as barometers containing two columns of mercury which one consists of a thermometer are considered falling within the derogation of paragraph 3 and therefore they should continue to be serviced. The columns can be repaired or replaced if these activities are part of the maintenance and repair services and preserve the cultural and/or historical value of the instrument.
Professionals may buy measuring devices containing mercury if they are destined for the repair and maintenance activities of antique measuring devices.
Is there any definition for measuring devices in the context of entry 18(a) of Annex XVII?

The REACH Regulation does not provide a definition of measuring devices (often referred to as measuring instruments). However, in the context of entry 18(a), it has to be noted that:

  1. The restriction provision in paragraph 1 of entry 18(a) covers those measuring devices that are intended for sale to the general public and provides an indicative list of these (thermometers, manometers, barometers, sphygmomanometers etc.)
  2. Furthermore paragraphs 5 and 7 provide exhaustive lists of mercury-containing measuring devices intended for industrial and professional uses which have not been allowed to be placed on the market after 10 April 2014 (barometers; hygrometers; manometers; sphygmomanometers; strain gauges to be used with plethysmographs; tensiometers; thermometers and other non-electrical thermometric application; mercury pycnometers; mercury metering devices for determination of the softening point; mercury triple point cells other than those used for the calibration of platinum resistance thermometers).

For the purposes of Directive 2004/22/EC on measuring instruments, ‘measuring instrument' means any device or system with a measurement function that is covered by Articles 1 and 3. According to the European Standardisation organisation-CEN, "measuring instruments allow for testing the accuracy and calibration of measuring devices (e.g. water meters, gas meters, electricity meters, etc.)". (http://www.cencenelec.eu/standards/sectors/mid/pages/default.aspx)

The abovementioned definitions provide an indication of what could generally be considered as a measuring device in the context of entry 18(a) of Annex XVII to REACH provisions.

Entry 19 of Annex XVII to REACH - Arsenic Compounds

Are imports of CCA treated wood from outside the European Union banned under Entry 19 of Annex XVII?
Under Entry 19 of Annex XVII to REACH, CCA type C cannot be used to treat wood in the EU due to the fact that it has not been authorised under Directive 98/8/EC. A request for authorisation could, however, be made in the future in line with the requirements of Directive 98/8/EC.
Concerning wood newly treated with CCA type C and imported from third countries:
· paragraph 4 a) authorises only the treatment of wood with CCA type C if this biocidal product is authorised under Directive 98/8/EC.
· under paragraph 4 b) it is stated that "Wood treated with CCA solutions in accordance with point a) may …."
This implies that all wood that is placed on the market in the EU must conform to the requirements of paragraph 4 a).
Therefore wood newly treated with CCA type C may only be placed on the EU market if this biocidal product used for treatment is authorised under Directive 98/8/EC.
Whilst the Directive does not impose general obligations on wood treatment installations outside the EU, this requirement is valid for any manufacturer, distributor, or importer placing wood on the EU market whether this wood is manufactured in the EU or manufactured outside
the EU and imported. Obviously the requirement does not apply to wood treatment installations outside the EU producing wood for marketing outside the EU.
In summary since 30 June 2007, it is prohibited to place on the market and to import wood newly treated with CCA type C, until such time as a biocidal product containing this active substance is authorised in line with all the requirements of Directive 98/8/EC.
Under Entry 19, paragraph 4b) of Annex XVII there is a list of applications for which wood treated with CCA type C can be used. May treated wood be used for other applications, such as railway sleepers other than underground railway sleepers?

Paragraph 4b) of Annex XVII to REACH concerning arsenic compounds provides for a list of applications for which wood treated with CCA may be used. This is not a list of examples of possible uses but an exhaustive list of authorised applications. It flows both from the actual wording of those provisions and from their objective that the derogation provided for in paragraph 4 must necessarily be subject to a strict interpretation, as confirmed by the Court of Justice (case C-358/11, pp. 40-43).

Consequently, wood treated with CCA cannot be used for other applications than the ones listed in paragraph 4 b). Wood treated with CCA can, therefore, not be used for railway sleepers installed above ground.

Entry 20 of the Annex XVII to REACH - Organostannic compounds

What types of organotin compounds are covered by entry 20 of Annex XVII of REACH "organostannic compounds"?

Organostannic compounds covered by entry 20 in Annex XVII to REACH, must contain a carbon-tin bond. Substances like tin salts or organotin compounds, for which tin is bound to an atom other than carbon (for example hexanoic acid, 2-ethyl-, tin(2+) salt (CAS-No. 301-10-0)) are not covered by entry 20 in Annex XVII to REACH.

What is the meaning of the expression "already in use" in the context of the entry 20 of Annex XVII to REACH?
Paragraphs 4(b), 5(b) and 6(b) of entry 20 of Annex XVII to REACH, state that articles (and mixtures in the case of article 5(b)) not complying with point (a) of the paragraph shall not be placed on the market after [a certain date] ‘except for articles that were already in use in the Union before that date'". 
 
The phrase ‘already in use' means in the possession of the end-user. Therefore, the derogations apply only to articles which reached end-users before the dates referred to in paragraphs 4(b), 5(b) and 6(b) of the entry. Those (second-hand) articles may continue to be traded after the dates on which the respective bans came into force. All articles still held by distributors, or in the storage facilities of importers or manufacturers on the dates when the bans came into force, should have been withdrawn from the distribution chain.
(a) Do toys fall within the scope of the dioctyltin (DOT) compounds restrictions of entry 20 (paragraph 6)? (b) Can toys benefit from the derogations for organotins in entry 20 of the Restriction List (Annex XVII)? (c) Would a paint coating on a toy that contains dibutyltin (DBT) as a biocide and not as a catalyst fall within the derogation?

(a) Yes, they do. Entry 20 in the Restriction List (Annex XVII) to REACH imposes DOT compounds restrictions for childcare articles, which are not toys. The REACH Regulation does not contain a definition of toys. The definition of toys in Directive 2009/48/EC on the Safety of Toys is illustrative in determining what should be considered as a “toy” in the context of this restriction (see Q&A 0982).

However, paragraph 6(a) of entry 20 restricts DOT compounds in textile toys as in any other textile article intended to come into contact with the skin. Furthermore, organic tin (including DOT) in toys is restricted by paragraph 13 of Part III (Chemical Properties) of Annex II to Directive 2009/48/EC on the safety of toys, which specifies maximum migration limits.

(b) and (c)

In addition to derogation in paragraph 5(d), the other derogations currently applicable to TBT, DBT and DOT compounds in articles relate to the continued placing on the market of articles that were already in use in the EU before the 1 July 2010 for TBT (paragraph 4(b), before the 1 January 2012 (paragraph 5(b)) for DBT and before the 1 January 2012 for DOT (paragraph 6(b)).

Does the restriction in entry 20 (organostannic compounds) of Annex XVII to REACH apply to packaging?

Yes. Packaging can be considered as an article (or a product composed of different articles) in its own right. More information can be found in the ECHA guidance on requirements for substances in articles available at https://echa.europa.eu/guidance-documents/guidance-on-reach (in particular in chapter 2). 

Therefore, with regard to entry 20, packaging should comply with the restrictions for tri-substituted (TBT, TPT) and dibutyltin (DBT) compounds. The restriction of dioctyltin compounds (DOT) which applies only to certain listed articles for the general public, applies to textile packaging.

Entry 23 of Annex XVII to REACH - Cadmium and its compounds

According to paragraph 10 of entry 23 of Annex XVII to REACH cadmium shall not be used or placed on the market if the concentration is equal to or greater than 0,01% by weight of the metal in metal parts of jewellery. Does this concentration threshold apply to each metal component of an item of jewellery or to the jewellery item as a whole?

With reference to paragraph 10 of the Annex to Commission Regulation (EU) 494/2011 amending entry 23 of Annex XVII of the REACH Regulation (cadmium) the concentration threshold of cadmium applies in each metal part of jewellery. The wording used by the legislator, i.e. "metal parts of the jewellery and imitation jewellery" implies that each metal part is relevant; therefore in order to determine if the restriction applies the calculation of the concentration in this case is to be done for each metal part. Therefore, if there are several metal layers as coatings on the surface of an inner (metallic) part of the jewellery these should be regarded as integral part of the metal part and the concentration limit of 0,01% is calculated for this whole metal part. In case the inner part is not metal, but the coating is made of metal layers, this coating is regarded as one metal part. If the jewellery article contains several metal parts, each of them should comply with the concentration limit.

Is it allowed to continue the sale/placing on the market of jewelry articles containing more than 0.01% of Cadmium, manufactured and already placed on the market (e.g. sold by the manufacturer to the distributor) before the 10 December 2011 following the entry into force of the new restriction according to Entry 23 of Annex XVII, paragraphs 10 and 11?

The prohibition of the placing on the market of jewellery and imitation jewellery articles containing cadmium includes sales from the manufacturers to distributors and from distributors to retailers, as well as imports. However, Commission Regulation (EU) 494/2011 contains derogation for articles that were placed on the market before 10 December 2011 (for the date see corrigendum published in OJ L 136/105). This means that jewellery and imitation jewellery articles placed on the market for the first time before 10 December 2011 do not need to comply with the prohibition thus they can be sold following entry into force of the new restriction for example to a retailer or on the second-hand market.

Which uses of brazing fillers containing cadmium can be regarded as uses for safety reasons (derogation in paragraph 9 of entry 23 of Annex XVII to REACH)?

Paragraph 8 of entry 23 of Annex XVII to the REACH Regulation states that cadmium and its compounds shall not be used in brazing fillers in a concentration equal to or greater than 0,01 % by weight. In addition, brazing fillers shall not be placed on the market if the concentration of cadmium (expressed as Cd metal) is equal to or greater than 0,01 % by weight. The paragraph also states that brazing shall mean a joining technique using alloys and undertaken at a temperature above 450°C. In accordance with the following paragraph 9, by way of derogation paragraph 8 shall not apply to brazing fillers used in defence and aerospace applications nor to brazing fillers used for safety reasons.

The safety aspect in relation to this derogation is if the use of cadmium containing brazing filler may prevent accidents causing human suffering or environmental pollution.

For the enforcement purposes examples of applications are given. It can be considered that the derogation on uses of cadmium containing brazing fillers for safety reasons in paragraph 9 of entry 23 covers the current uses, such as:

  1. Brazing fillers used in turbine wheels in power plant technology in temperature below 650°C.

    Turbine wheels in power plant technology are parts of speed drivers for gas compressors and boiler feed pumps, where rotational speed is approximately from 1000 revolutions per minute (rpm) up to 20 000 rpm. Cadmium containing brazing fillers are needed as they can be used below 650 °C without decreasing the strength of the parent material (base metal).  Cadmium-free brazing fillers require higher temperatures which causes the weakening of the parent material.  Weakening of the parent material could lead to the breakdown of the turbine wheel. Due to high rotational speed the parts and pieces of shrapnel may cause injuries to workers and others in the vicinity of the wheel.  The breakdown of the turbine wheel may result also in a complete shutdown of the power plant, the compressor station of a gas pipeline, or of a refinery.
     
  2. Brazing fillers used in pipes and tubes where acetylene is transferred in high pressure (1.5 – 17 bar).

    Cadmium containing brazing fillers are needed in the joining process for pipes and tubes, where acetylene is transferred in order to avoid formation of explosive substances.  Acetylene forms explosive substances with copper and silver as well as other materials (e.g. formation of copper acetylide and silver acetylide).  Cadmium reduces the overall percentage of copper and silver in the brazing fillers to the level where formation of explosive substances does not exist. Another reason to use cadmium in brazing fillers for this application is that cadmium facilitates the capillary action and solder penetration ensuring a good quality joint with high integrity for pipes and tubes where acetylene is transferred in high pressure (1.5-17 bar). Release of acetylene from pipes and tubes may as well cause serious risk, as acetylene is extremely flammable gas and explosive with and without contact with air.

Other applications that would like to benefit from the derogation need to show the similar kind of safety aspects as described above.

Such considerations should take into account the availability on the market of cadmium-free brazing fillers which can address the safety aspects of the specific application of the brazing fillers in an equivalent manner.

See also ECHA´s report "The use of brazing fillers containing cadmium for safety reasons" [PDF].

Which types of articles coloured with mixtures containing cadmium can be regarded as using cadmium for safety reasons (derogation in paragraph 3 of entry 23 of Annex XVII to REACH)?

Paragraph 1 of entry 23 of Annex XVII to the REACH Regulation provides a restriction on cadmium and its compounds in mixtures and articles produced from certain synthetic organic materials (plastic materials) and paragraph 2 provides a restriction on cadmium and its compounds in paints (Tariff codes 3208 and 3209). The following paragraph 3 states that by way of derogation the restrictions in paragraphs 1 and 2 do not apply to articles coloured with mixtures containing cadmium for safety reasons.

There are two safety aspects in relation to this derogation. The first relates to the use of a specific colour or pigment with certain properties which is necessary to prevent accidents. The second relates to the use of a specific colour or pigment with certain properties in safety equipment.

For the enforcement purposes example of applications are given. Based on above, it can be considered that the derogation in paragraph 3 of entry 23 covers current applications of articles such as:

  1. Coloured wire insulation and cable jackets used in aircraft electrical and control systems for the purpose of fire detection and extinguishing systems, flight control systems or during flight tests.

    The wire and cable connections are often used in in a high temperature application (greater than 150ºC ambient temperature). Cadmium pigments are used to keep the colour from changing or fading over time in the high temperature. Changing established colour conventions could introduce a significant risk of maintenance errors, which may lead to a risk of passengers.
     
  2. Outdoor safety equipment, such as:
    • parts of rescue boats for ships (e.g. safety belts, water pockets of life rafts, canopies) and
    • parts of safety equipment for outdoor applications (e.g. seats, reels and diverse technical parts).
    Outdoor safety applications are applications used typically in outdoor activities in areas where visible colours are needed for rescue or orienteering purposes in case of emergency situations. Cadmium pigments provide highly visible colour contrast with its surroundings (e.g. in rescue situations) and where durability of the colour for the ambient environment (e.g. weather resistance, light fastness, heat resistance and chroma) is needed.

The other applications that would like to benefit from the derogation need to show the similar kind of safety aspects than described above.

Such considerations should take into account the availability on the market of alternative substances which can address the safety aspects of the specific application in an equivalent manner.

See also ECHA´s report "The use of cadmium and its compounds in articles coloured for safety reasons" [PDF].

What parts of plastic coated copper beads (CCB) used in jewellery should comply with the cadmium restriction entry 23?

Entry 23 (paragraph 10 (i)) of Annex XVII to the REACH Regulation states that cadmium and its compounds must not be used or placed on the market if the concentration of cadmium is equal to or greater than 0,01 % by weight of the metal in metal beads and other metal components for jewellery making (see Q&A, 158). In addition, it should be noted that articles produced from plastic material referred to in paragraph 1 of the entry must not be placed on the market if the concentration of cadmium is equal to or greater than 0.01 % by weight of the plastic material.

Thus, in the case of plastic coated metal beads (CCB beads), both the plastic material and the metallic part of the bead need to comply with entry 23 (cadmium restriction).

Please also note that if the article is painted, then paragraph 2 will also apply to this article.

Do paragraphs 5 and 6 of entry 23 (cadmium and its compounds) cover unplated metal parts?
No. They cover only plated metal parts. Paragraphs 5 and 6 of entry 23 prohibit the use of cadmium for “cadmium plating” (defined as a deposit or coating on a metallic surface with metallic cadmium) metallic articles used in specified sectors/applications. The placing on the market of cadmium-plated articles used in those sectors/applications and of articles manufactured in some of those sectors/applications is also prohibited. The latter reference to “articles manufactured” must be taken to mean articles that have been cadmium plated, since paragraphs 5 and 6 relate only to “cadmium plating”. Accordingly, Paragraphs 5 and 6 do not cover articles with metal parts containing cadmium unless these parts are plated with cadmium. 
Note that metallic articles containing cadmium may be covered under other EU legislation. For example, (1) electrical and electronic equipment falls under Directive 2011/65/EU on the Restriction of the use of certain Hazardous Substances and must comply as well with the maximum concentration limits for cadmium set in that Directive and (2) toys are covered under Directive 2009/48/EC on the Safety of Toys.
Is ink covered by entry 23 of Annex XVII to REACH, concerning cadmium and its compounds?
No. Ink is not included in the TARIC codes [3208] [3209] which define the scope of paragraph 2 of entry 23. 
Entry 27 of Annex XVII to REACH - Nickel and its compounds

Are mobile telephones covered by the restriction set in Entry 27 of Annex XVII on nickel?

Entry 27 of Annex XVII to REACH states that nickel may not be used "in articles intended to come into direct and prolonged contact with the skin, if the rate of nickel release from the parts of these articles coming into direct and prolonged contact with the skin is greater than 0.5 Jg/cm²/week". The aim of this restriction to protect consumers against nickel allergy which may be caused by prolonged contact of the skin with nickel-releasing articles that come into direct and prolonged contact with the skin such as jewellery, buttons, tighteners, zips and rivets in items of clothing. It has emerged that some mobile telephones contain nickel in surface material and that consumers are at risk of developing eczema through skin contact with the mobile telephone. As mobile telephones are clearly intended to come into direct contact with the skin, and as they are used on a daily basis often for prolonged periods of time, it is considered that mobile telephones fulfil the condition of "direct and prolonged contact with the skin". Therefore mobile telephones are covered by the restriction and should comply with the conditions set in Entry 27 of Annex XVII to REACH.

How to clarify the "prolonged contact with the skin" in relation to the nickel restriction entry 27?

Prolonged contact with the skin is defined as contact with the skin to articles containing nickel of potentially more than

  • 10 minutes on three or more occasions within two weeks, or
  • 30 minutes on one or more occasions within two weeks.

The skin contact time of 10 minutes applies when there are three or more occasions of skin contacts within a two-week time period. The skin contact time of 30 minutes applies when there is at least one occasion within a two-week time period.

Details

 

 

Entry 28 to 30 of Annex XVII to REACH - CMR substances

Are substances classified as CMRs, and included in Annex VI to CLP but not yet included in the Appendices 1-6 of Annex XVII to REACH, covered by the restrictions in entries 28-30 of Annex XVII to REACH?
No, only substances listed in the relevant Appendices (1 - 6) of Annex XVII are covered by the restrictions in entries 28 - 30.
 
When substances are classified for the first time as CMR and included in an ATP of the CLP Regulation, the European Commission prepares a draft amendment to include these substances in the Appendices of REACH Annex XVII. The amendment then has to be adopted in accordance with Article 68(2) of REACH, before the new substances are covered by entries 28-30.
Entries 28-30 of Annex XVII restrict substances that are carcinogenic, mutagenic and toxic to reproduction (CMR). Do these restrictions apply to these substances when they are present in articles?

Substances within the scope of entries 28-30 are not allowed to be placed on the market or used for supply to the general public as substances, as constituents of other substances or in mixtures when the concentration is equal to or greater than the specified limits. Certain derogations apply to this restriction as listed in paragraph 2. CMR substances that are present in articles are not within the scope of the restriction imposed by entries 28-30, but other restrictions may be applicable to these substances, when present in articles. In addition, notification and communication obligations under REACH may apply; see the ECHA website: https://echa.europa.eu/regulations/reach/candidate-list-substances-in-articles/notification-of-substances-in-articles.

It should be noted that entries 28 and 29 are applicable to the substances that are listed in Appendices 1 & 2 (carcinogenic (C), categories 1A and 1B) and Appendices 3 & 4 (mutagenic (M), categories 1A and 1B). Entry 30 is applicable to substances which are classified as reproductive toxicants (R), categories 1A and 1B and listed in Appendices 5 and 6. These Appendices are regularly updated by including new substances, after the adoption of a harmonised classification for a substance as CMR, category 1A or 1B according to Regulation (EC) No 1272/2008.   

Entry 31 of Annex XVII to REACH - Creosotes in wood

What is the meaning of the expression "second hand market for re-use" in paragraph 2(c) of entry 31 of Annex XVII to REACH?
Paragraph 1 of entry 31 prohibits the placing on the market of wood treated with the substances listed in points (a) to (i) of column 1 of the entry, whether as substances on their own or as mixtures. Paragraph 2(c) of entry 31 states that "….the prohibition in paragraph 1 on the placing on the market shall not apply to wood which has been treated with substances listed in entry 31 (a) to (i) before 31 December 2002 and is placed on the second-hand market for re-use….."
 
This derogation therefore concerns wood that had already been treated with the substance listed in points (a) to (i) of column 1 of entry 31 before 31 December 2002. The intention of the derogation is to allow second-hand wood treated before 31 December 2002 with the substances covered by this entry to be traded by the end-user and subsequent users. This type of derogation is often included in restriction entries to avoid enforcement difficulties.
It should be noted that the conditions in paragraph 3 apply to second-hand wood benefiting from the derogation in paragraph 2(c). Thus, it cannot be used e.g. inside buildings, in toys, in playground etc.
Entry 40 of Annex XVII to REACH - Flammable substances in aerosol generators for entertainment and decorative purposes

Entry 40 of Annex XVII prohibits the use of flammable, highly flammable or extremely flammable substances in "aerosol generators placed on the market for the general public for entertainment and decorative purposes". Are aerosol generators containing coloured hairsprays and glitter for the body and sold to the general public restricted under this entry?
 Entry 40 provides an indicative list of examples of products that are covered by the restriction. These examples are all products to be used for the decoration of venues for festivities/parties and for use during parties. None of these examples are cosmetic products within the meaning of Regulation (EC) No 1223/2009 on cosmetic products.
Article 67(2) of REACH excludes cosmetic products as defined by Directive 76/768/EEC (now Regulation (EC) No 1223/2009) from the scope of restrictions when they target risks to human health within the scope of that legislation. This restriction on aerosol dispensers is entirely linked to the human health of consumers, which are fully addressed by Regulation (EC) No 1223/2009. 
Therefore, the restriction in Entry 40 of Annex XVII to REACH, prohibiting the use of flammable, highly flammable or extremely flammable substances in "aerosol generators placed on the market for the general public for entertainment and decorative purposes", does not cover aerosol dispensers which are cosmetic products. Coloured hair sprays and body glitter fall within the definition of cosmetic products in Regulation (EC) No 1223/2009 as they are intended "to be placed in contact with an external part of the human body" with a view to "changing its appearance". They have a similar use to more classical cosmetic products, such as normal hair sprays and should not be considered as having an entertainment or decorative purpose within the meaning of the entry.
Are there any definitions for aerosols, aerosol dispensers, in the context of Entry 40?

The REACH Regulation does not define aerosols or aerosol dispensers.
According to the ordinary meaning of the word, an aerosol is considered to be "a substance enclosed under pressure and released as a fine spray by means of a propellant gas". (Oxford advanced dictionary definition). The term may in certain contexts be used for a mixture enclosed under pressure and released as a fine spray by means of a propellant gas, or the dispenser or package used to change the ingredient inside the container into a spray by the use of a propellant gas. The European Aerosol Federation uses the term "aerosol" for both the suspension and the dispenser/package.

Furthermore, it should be noted that according to Article 2.3.1 of the CLP Regulation (for "Classification, Labelling and Packaging"), the term "aerosol dispenser" means: any non-reusable container made of metal, glass or plastic and containing a gas compressed, liquefied or dissolved under pressure, with or without a liquid, paste or powder, and fitted with a release device allowing the contents to be ejected as solid or liquid particles in suspension in a gas, as a foam, paste or powder or in a liquid state.

The CLP definition is very similar to the definition provided in Article 2 of the Aerosol Dispensers Directive (ADD) (75/324/EEC).
The above definitions provide an indication of what could be generally considered as ‘aerosols/aerosol dispensers' in the context of Entry 40 of Annex XVII. Note that aerosol generators should be regarded as aerosol dispensers, as the original restriction discusses aerosol generators.

What is the meaning of products for entertainment and decorative purposes in the context of entry 40 of Annex XVII? Are aerosol dispensers containing coloured hairsprays and glitter for the body and sold to the general public restricted under this entry?

Entry 40 prohibits the use of flammable, highly flammable or extremely flammable substances in "aerosol dispensers where these aerosol dispensers are intended for supply to the general public for entertainment and decorative purposes". Paragraph 1 provides an indicative list of examples of products that are covered by the restriction. These examples are all products to be used to decorate, for instance, venues for festivities (e.g. Christmas, weddings, and carnivals) or parties (e.g. birthday parties and fancy-dress parties) and for entertainment use, for instance, during festivities and parties. None of the examples listed in the entry are cosmetic products within the meaning of Regulation (EC) No 1223/2009 on cosmetic products.

Coloured hair sprays and body glitter would fall within the definition of cosmetic products in Regulation (EC) No 1223/2009, as they are intended "to be placed in contact with an external part of the human body" with a view to "changing its appearance" and therefore have a similar use to more classical cosmetic products, such as normal hair sprays. Coloured hair sprays and body glitter should not be considered as having an entertainment or decorative purpose, and therefore they are not covered by entry 40 of Annex XVII to REACH.

Entry 43 of Annex XVII to REACH - Azocolorants and Azodyes

Are optical brightening agents (OBAs) azodyes within the meaning of the Entry 43 to Annex XVII?

Through a literature search and consultation with experts in this area it was not found any structural connection between optical brighteners (or better called fluorescent dyes) and azodyes since either the NH bonds in the fluorescent dyes are connected to heterocyclic NC structures and therefore cannot form any of the 22 banned arylamines or they do not contain any azo bonds where reductive cleavage could take place to generate any of the aromatic amines covered by the azodyes ban. Therefore at the present time, this information confirms that the restriction in Entry 43 to Annex XVII does not cover optical brightening agents (OBAs). Should the chemical structure of optical brightening agents be different from the definition as reported above, this answer may change accordingly.

The restriction indicated in entry 43(3) applies only to the placing on the EU market of substances or mixtures containing the azodyes listed in Appendix 9 at a concentration exceeding 0.1% by weight, and to the use of such substances/mixtures within the EU. Does the restriction therefore not apply to imported articles which have been dyed with the azodyes listed in Appendix 9?

Entry 43(3) of Annex XVII restricts the placing on the market of substances and mixtures containing over 0.1% of the azodyes listed in Appendix 9, when they are intended for colouring textile and leather articles, and also the actual use of the substance or mixture for that purpose. Therefore, the presence of these substances in imported articles is not restricted.

However, pursuant to paragraphs 1 and 2 of the restriction, if an azodye in Appendix 9 releases one or more of the aromatic amines listed in Appendix 8 in a concentration above 30 mg/kg (0,003 % by weight, it cannot be used in textile and leather articles which may come into direct and prolonged contact with human skin or the oral cavity (such as those listed in paragraph 1). Those textile and leather articles cannot be placed on the market unless they comply with that concentration limit.

Is the list of restricted items in entry 43 of Annex XVII to REACH concerning azocolourants and azodyes exhaustive?
No. The use of the words “such as” makes clear that the list of items mentioned in paragraph 1 of entry 43 of Annex XVII to REACH is a non-exhaustive list of examples of items covered by this restriction (clothing, footwear, textile toys etc.). 
Do sofas and chairs (e.g. garden chairs/sun loungers’ type) fall under the scope of the restriction entry 43 of Annex XVII to REACH?
Yes. Garden furniture made of textile or leather is covered by entry 43 as people who use them can be in light clothing (even in bathing suits or bare) and “direct and prolonged contact with human skin” is very likely. There is even a direct reference to chair covers in the list of examples of articles covered by the restriction. 
Entry 46 of Annex XVII to REACH - Nonylphenol.

Does the entry 46 of Annex XVII cover traces in cosmetic products?
Regulation 1223/2009 on cosmetic products, that repealed Directive 76/768/EEC, introduces a ban on the marketing of cosmetic products containing nonylphenol (CAS: 25154-52-3) and 4-nonylphenol, branched (CAS: 84852-15-3). Pursuant to Article 17 of the cosmetics Regulation, the presence of traces in cosmetic products is allowed, provided that such presence is technically unavoidable in good manufacturing practice and that the product does not cause damage to human health.  
Entry 46 of Annex XVII to REACH bans the placing on the market of nonylphenol and nonylphenol ethoxylates as a substance or in mixtures in a number of applications including cosmetic products, when the concentration is higher than 0.1% by weight. The objective of entry 46 is the protection of the environment. Therefore Article 67 (2) of REACH does not apply. Entry 46 covers traces in cosmetic products to the extent that their presence presents a risk to the environment. The application of entry 46 of Annex XVII to REACH is complementary to, and does not conflict with, Regulation (EC) No 1223/2009. 
 
Does the entry 46 of Annex XVII cover all nonylphenols?

Yes. The intention of the legislator was to cover all isomers, linear and branched, of nonylphenol and their ethoxylates and therefore all of them are covered by the restriction.

The restriction on nonylphenol and nonylphenol ethoxylates was based on the risks identified in the risk assessment report prepared by the United Kingdom under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances. The risk assessment report states that "It is understood that nonylphenol (CAS Number: 25154-52-3) as originally defined by CAS (Chemical Abstract Service) covered all nonylphenols. However, subsequent revisions redefined it to cover only straight chain nonylphenol, other isomers having different CAS numbers. Given the method of manufacture of nonylphenols, very little if any straight chain nonylphenol is produced. That which is produced is only likely to be present at very low levels in commercial mixtures. The commercially produced nonylphenols are predominantly 4-nonylphenol with a varied and undefined degree of branching in the alkyl group. This assessment covers commercially produced material (predominantly 4-nonylphenol, branched). This material will also contain smaller amounts of other isomers and impurities, and falls under the CAS Number 84852-15-3."

Therefore Council Directive 76/769/EEC, as amended by Directive 2003/53/EC, did not specify any CAS or EC numbers for nonylphenol. In the revision of the REACH restriction by Regulation 552/2009/EC, which made several technical changes, the CAS and EC numbers were added. This will be corrected by a technical amendment to reflect the intention of the legislator.

What are personal care products in entry 46?

Paragraphs (1) to (9) of entry 46 list the ‘purposes' to which the restriction applies. Following paragraph (7) "cosmetic products" is paragraph (8) "other personal care products". It therefore seems that cosmetics are to be considered as a subcategory of personal care products.

REACH does not define "cosmetic products". According to Regulation (EC) No 1223/2009 on cosmetic products,  "cosmetic product" means "any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance protecting them, keeping them in good condition or correcting body odours."

Based on the above, it can be interpreted that "other personal care products" within the meaning of entry 46 include, but are not limited to, any product meeting the conditions indicated in the above definition for substances and mixtures and other products used for personal hygiene, such as toilet papers, some female hygiene products, nappies, cotton pads, etc. This interpretation can be broadly considered as a perception of the average consumer for this product category. 

Entry 48 of Annex XVII to REACH - Toluene

For adhesive tapes, does the concentration limit for toluene of 0.1% in adhesives as specified in Entry 48 of Annex XVII apply to the whole mass of the tape or just to the mass of the adhesive layer on the tape?

Entry 48 prohibits the placing on the market for supply to the general public of toluene as a substance or in mixtures, in a concentration equal to or greater than 0.1% by weight, where the substance or the mixture is used in adhesives and spray paints. Adhesive tapes consist of a layer of adhesive coated on a flexible substrate. As the restriction concerns the concentration of toluene in adhesives, the concentration of toluene must be calculated with reference to the amount of adhesive on the tape, and not with reference to the total weight of the adhesive and substrate.

Entry 50 of Annex XVII to REACH - Polycyclic aromatic hydrocarbons (PAHs)

What is an interpretation of the "major operational change" concerning the requirement to control the calibration of the PAH/PCA ratio after each "major operational change" under Entry 50 to Annex XVII?

As stated in Recital 8 of the Directive 2005/69/EC (OJ L323, 9.12.2005, p.51), there are at present no harmonized test methods for measuring PAHs in the extender oils, or for measuring PAHs in tyres that contain such oils. Until suitable harmonized methods are available, the only named method that is permitted for measuring the PAH content of extender oils is the IP346 analysis method. This method is permitted providing that certain additional conditions are met. These additional conditions are necessary because the IP346 method does not measure the PAH content directly. In fact IP346 measures the total content of polycyclic aromatic compounds (PCA) rather than the PAH content. The PCAs are a group of substances to which PAHs belong, but in which PAHs are present in only very small amounts. The legal limit for PAHs in extender oils, which is 1 part per million (ppm) of BaP and 10ppm total PAH content, is considered to be met if the total PCA content is <3%. In other words, the PCA content of 3% is taken as a proxy measurement for a PAH content of 10ppm. The proxy measurements will be valid only if the ratio between the PAH and PCA content in the extender oil is known and does not change over time. The additional conditions therefore require an initial calibration of the technique (measurement of the PAH/PCA ratio) and recalibration at intervals of six months, or after "major operational change", in order to ensure that the measurements remain valid over time. The term "major operational change" should therefore be taken to mean any change in materials or processes that could invalidate the results of the proxy measurement. The principle cause of invalid results would be a change in the PAH/PCA ratio in the extender oil. However, it should be remembered that not only is IP346 a proxy method for measuring PAH, but that the quantity that it does measure, namely PCA content, is meaaured in a rather indirect way, namely by a change in the refractive index of a solution, and that PCAs are not the only substances that affect the refractive index of a solution. The potential for obtaining invalid results is therefore quite high and the method should therefore be used with considerable caution. It would therefore be advisable to recalibrate in case of doubt. The provision to control the calibration of the PAH/PCA ratio every six months is to safeguard the validity of the IP346 results against unintentional or unknown changes. This would apply for the case where the manufacturing process and materials used remain the same, and where there is no reason be expect a change in the PAH/PCA ratio. However, it is possible to imagine, for example, that a tyre manufacturer receives a reformulated extender oil from his supplier without being made aware of the change that has been made, and the results from the IP346 could be invalidated as a consequence. A six month recalibration interval was considered sufficient to cover such occurrences. Conclusion: The provision to control the calibration of the PAH/PCA ratio after each "major operational change" is to safeguard the validity of the IP346 results. A major operational change is therefore a deliberate change to materials or processes that might be expected to significantly influence the PAH/PCA ratio, or otherwise affect the validity of the measurement. Examples of such a change would be where the source of supply for the extender oil is changed, or where the method of using the oil is changed. Judgment of whether a particular change is sufficiently important to trigger the need for recalibration will necessarily be made case-by-case and will require expert opinion.

Does the restrictions provided in Entry 50 concerning on PAHs in tyres cover mobile machinery?
Entry 50 to Annex XVII as enacted by Commission Regulation 552/2009 restricts the use of PAH in tyres for "vehicles covered by Directive 2007/46/EC establishing a framework for the approval of motor vehicles and their trailers".
Article 2 of Directive 2007/46 defines its scope. Paragraph 1 lists the vehicles designed for use on roads.
Article 2 of Directive 2007/46, Paragraph 3 lists the following vehicles:
a) vehicles designed and constructed for use principally on construction sites or in quarries, port or airport facilities;
b) vehicles designed and constructed for use by the armed services, civil defence, fire services and forces responsible for maintaining public order;
c) mobile machinery.
Article 2 of Directive 2007/46, paragraph 4 lists the following vehicles:
a) vehicles intended exclusively for racing on roads;
b) prototypes of vehicles used on the road under the responsibility of a manufacturer to perform a specific test programme provided they have been specifically.
In addition the definition of "motor vehicle" in point 11 of Article 3 requires that the vehicles covered should have a maximum design speed limit exceeding 25 km/h. In conclusion the restriction in Entry 50 covers the tyres for vehicles listed in the Article 2 paragraph 1, 3 and 4 of Directive 2007/46/EC which have a maximum design speed limit exceeding 25 km/h. Tyres of mobile machinery with a maximum design speed limit exceeding 25 km/h are therefore covered by the restriction and have to comply with the conditions set in the entry 50.
Does the restrictions provided in Entry 50 of Annex XVII concerning on PAHs in tyres cover "Standard reference tyres"?

Standard reference tyres are produced and imported solely for the purpose of providing a reference performance for other newly developed tyres. They are not placed on the market to be fitted on vehicles intended for final users. For the purpose of entry 50, tyres are defined as tyres for vehicles covered by Directives 2007/46/EC on motor vehicles and their trailers, Directive 2003/37/EC on agricultural or forestry tractors, and Directive 2002/24/EC on two and three-wheeler motor vehicles. It appears that Reference Tyres are not intended to be used on vehicles covered by the Directives 2007/46/EC, 2003/37/EC and 2002/24/EC. In conclusion these tyres should not be considered as covered by the provisions of the restriction in Entry 50 of Annex XVII.

Can you give examples of articles that are covered by or excluded from Entry 50 (paragraphs 5 and 6) of Annex XVII to REACH: Polycyclic aromatic hydrocarbons in articles supplied to the general public?
This document aims at providing a guideline concerning the interpretation of the scope of the restriction provisions in paragraphs 5 and 6 of entry 50 of Annex XVII to REACH Regulation (EU) No 1907/2006 on polycyclic aromatic hydrocarbons in articles supplied to the general public. It has been drawn up to (i) clarify certain terms that define the scope of the restriction (e.g. “plastic and rubber component”, “direct as well as prolonged contact or short-term repetitive contact with human skin or the oral cavity", "normal/reasonably foreseeable conditions of use") and (ii) provide non-exhaustive lists of article types which fall within (or out of) the scope of the restriction.
Entry 51 and 52 of Annex XVII to REACH - Phthalates in toys and childcare articles

In Entries 51 and 52 of Annex XVII respectively it is stated that the substances DEHP, DBP and BBP on the one side and the substances DINP, DIDP and DNOP on the other side "shall not be used as substances or or in mixtures, in concentrations of greater than 0.1% by weight of the plasticised material…". Does the 0.1% limit apply to each phthalate listed individually, or whether it applies to the 3 or 6 phthalates combined? How should this limit of 0.1% be applied when a product contains traces of more than one these substances?

The threshold of 0.1% is the standard threshold used in Annex XVII. The value of 0.1% has been chosen because it represents a measurable quantity. It is being used to take into account impurities, not to allow the use of certain substances, e.g. phthalates in toys and childcare articles. One should be aware that in order to plasticise a toy or childcare article concentrations of phthalates of more than 10 per cent are needed. Different restrictions are applied to each of the two groups of phthalates. The limit value of 0.1% should therefore be applied for each group of phthalates combined, i.e. the concentration of DEHP, DBP and BBP combined should not be higher than 0.1% and the concentration of DINP, DIDP and DNOP combined should also not be higher than 0.1%. Conclusion: A toy or childcare article would not comply with the Entry 51 or Entry 52 respectively if it contained either more than 0.1% of DEHP, DBP and BBP combined or more than 0.1% of DINP, DIDP and DNOP combined. However, it would be considered compliant if it contained only 0.09% of DEHP, DBP and BBP combined and 0.09% of DINP, DIDP and DNOP combined.

Are the articles destined to be used for the hygiene of children such as bathtubs, articles for the bath, bathtub mats, hairbrushes, bath thermometers, or nail cutters covered under Entries 51 and 52 of Annex XVII?

The entries 51 and 52 specify that "Childcare article" means "any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children." As these articles are intended to facilitate the hygiene of children they should be considered as "childcare articles" as defined by the entries 51 and 52. In conclusion, articles which are used for the hygienic care of children such as bathtubs, articles for the bath, bathtub mats, hairbrushes, bath thermometers, or nail cutters are therefore covered by the Entries 51 and 52 and use of phthalates and should conform to the prescriptions of the entries.

Do mattress protectors (covers, pads etc.) fall within the scope of Entries 51 and 52 of Annex XVII?

The definition of childcare articles contained in Annex XVII to REACH is as follows: "Childcare articles" are defined as "any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children". Further explanation is provided by the Commission services' guidance document on the interpretation of the concept "which can be placed in the mouth". It gives the following examples: "The main purpose of pyjamas is to dress children when sleeping and not to facilitate sleep. Pyjamas should therefore be regarded as textiles and, like other textiles, do not fall under the scope of the Directive. Sleeping bags are designed to facilitate sleep, and should therefore fall under the Directive." Taking this into account, and also taking into account that the guidance document explicitly contains a description and a photo of a mattress cover, it can be confirmed that mattress protectors are childcare articles as defined in Annex XVII. This means that the three phthalates DEHP, BBP and DBP listed in entry 51 of Annex XVII may not be used in mattress protectors. The other three, DINP, DIDP and DNOP, listed in the entry 52, are only restricted in those articles that can be placed in the mouth by children.

Can mattress protectors (covers, pads etc.) be placed in the mouth by children within the meaning of Entries 51 and 52 of Annex XVII?

The guidance document contains an example of a mattress cover that is not directly mouthable in normal and foreseeable use conditions. The edges and corner are not accessible for mouthing by the child – by design (the mattress should fit snugly in the cot to avoid entrapment risks), and the mattress is covered with a sheet in normal use and the surface is sufficiently taut (by design – to avoid suffocation risks) to prevent PVC from being mouthed through the sheet. This is based on the observation that inaccessible parts of articles can not be taken into the mouth. Articles or parts of articles should be considered inaccessible if, during proper use or reasonably foreseeable improper use by children, they can not be reached. However, there will be other cases when parts of certain articles can be taken into the mouth under normal and foreseeable conditions, for example when the mattress protector is placed on the sheet or cannot be completely fixed. In conclusion, mattress protectors that can be placed above sheets or that cannot be tightly fixed to the mattress have to comply with the restriction contained in entry 52 of Annex XVII to REACH. Authorities competent for market surveillance should assist manufacturers/importers in making a case-by-case assessment on the basis of the criteria described above and in the guidance document.

Is the substance Di-2-propyl heptyl phthalate (DPHP), CAS No 53306-54-0 restricted under Entry 52 of Annex XVII or is DPHP as a new compound different from DIDP and therefore not covered by the restrictions in Entries 51 and 52?

The restriction in entry 52 concerns the substance "Di-isodecyl phthalate" (DIDP) which is listed with CAS Numbers 26761-40-0 and 68515-49-1. Di-2-propyl heptyl phthalate (DPHP) is an isomer of decyl phthalate and has the CAS No 53306-54-0. According to the information at the Commission's disposal, DPHP (CAS # 53306-54-0) is different from DIDP and therefore not covered by entry 52 of Annex XVII. In conclusion, the substance is not covered under the entry 52 of Annex XVII. The uses of the substance may be regulated in the future on a Community-wide basis, if it appears from the information which will become available that it causes unacceptable risks to human health or the environment. In addition DPHP is explicitly not promoted by its manufacturers for use in toys, food packaging or medical products.

What is the interpretation of the concept "which can be placed on the mouth" as laid down in the entry 52, concerning toys and childcare articles?

Guideline on the interpretation of the concept "which can be placed in the mouth" as laid down in the entry 52 of Annex XVII to REACH Regulation 1907/2006.

This guideline aims at providing some criteria and examples to help identify those toys and childcare articles which can be placed in the mouth by children. The guideline lists the main criteria of "size dimension" and "accessible parts" (according to the EN 71-European Standard on the safety of toys) which would therefore facilitate the judgement - on a case by case – whether a toy or childcare article can be placed in the mouth by children.  The guideline also provides pictures as examples in order to better indicate which toys and childcare articles or parts of them can be taken into the mouth.  

Do blankets and objects to facilitate the transport of children fall within the scope of Entries 51 and 52 of Annex XVII?
The Guideline on the concept "which can be placed in the mouth" [See Q&A 748], provides certain clarifications concerning the types of childcare articles within the scope of Entries 51 and 52 of Annex XVII. For instance, sleeping bags are claimed to be articles designed to facilitate sleep, and should therefore fall under the scope of Entries 51 and 52. In addition, the guidance document explicitly contains a photo of a mattress cover which is considered as childcare articles, also explaining that certain parts (e.g. mattress protectors) can be placed in the mouth by children. [See Q&A 675]. 
 
Blankets are, in nature, articles similar to mattresses as both used in bed to facilitate the sleeping of children and therefore can be claimed to meet the broad definition of childcare articles. Furthermore, since blankets can be commonly placed in mouth by children, these can be considered within the scope of both Entries 51 and 52 of Annex XVII. 
 
The Guideline clarifies that "entry 52 of Annex XVII on what can be placed in the mouth by children also covers the accessible parts of articles such as push chairs, car seats, sleeping bags and bike seats which are intended to facilitate sleep and relaxation during transport". Given that child seats and items which are used for transportation of children are quite similar in function and design to the above mentioned types of articles, they can be broadly considered as childcare articles [See Q&A 983]. In addition, it is noted that pictures of such types of childcare articles are also provided at the end of the Guideline. Over there, examples of mouthed items of such articles are provided to assist enforcers conclude whether they fall (or not) under the scope of entry 52. 
In entry 51 of Annex XVII to REACH, does the concentration limit "0,1 % by weight of the plasticised material in toys and childcare articles" relate to the whole article or only part of it?". For instance, if only the head of a doll contains more than 0.1 % w/w phthalates, should the concentration be calculated on the total weight of the plasticised material of the whole toy or only for the weight of the plasticised material of the head?

The 0.1% limit was set up in order to eliminate the use of phthalates. Such limit was set up in order to be respected in each bit/piece of plasticised material by itself, regardless of whether there are other pieces or not. Therefore the reference to 0.1%, intended also as the sum up to the 3 phthalates, has to be calculated in each piece of plasticised material of each homogenous material. In the example referred to in the question the calculation should therefore be based on the weight of the plasticised material of the head of the doll and not the entire weight of all plasticised material of the whole toy.

Does a baby monitor fall under the definition of childcare article in the context of entries 51-52 of Annex XVII to REACH?

A childcare article is defined by entries 51 (4) and 52(4) as "any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children" (see Q&A 983). A baby monitor does not facilitate the sleep or relaxation of the baby, it allows parents to be alerted when the baby is crying or making other noise. Therefore baby monitors fall outside the scope of entries 51-52 of Annex XVII.

Do entries 51 and 52 of Annex XVII of REACH cover certain articles often used by children (e.g. school supplies, clothing or hair accessories)?
No, items such as school supplies, clothing or hair accessories are not considered as toys in the sense of the Directive 2009/48/EC on the safety of Toys, as their main purpose is not to be used in play by the children. However, certain products such as plastic combs can fall under the definition of ‘childcare articles’ (defined in the restriction as any products intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children) see (Q&A 0983). 
Entries 51 and 52 restrict the placing on the market and use of phthalates in toys and childcare articles. Does this restriction apply to medical devices, such as nebulisers?
Medical devices are defined in Article 2 of Regulation (EU) 2017/745 (see: https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en#current_legislation). Entries 51 and 52 pose restrictions on certain phthalates in plasticised materials in toys and childcare articles. Medical devices are generally regarded to have functions different from those of toys and childcare articles. Childcare articles are defined in entries 51 and 52 as ‘…any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of the children’. Whether a medical device is a childcare article for the purpose of entries 51 and 52 should be assessed on a case-by-case basis. In the example of a nebuliser, the device is intended for administering a medicinal product (apparatus to be used for treatment) and therefore it is not a childcare article and the restriction does not apply to it.
Entry 56 of Annex XVII to REACH - Methylenediphenyl diisocyanate (MDI)

Does the entry 56 of Annex XVII cover, besides the MDI monomers, also the oligomers and polymers of MDI?

The polymeric MDI, with CAS number 9016-87-9, is not included in the definition of the substance with CAS 26447-40-5 and moreover is not classified as dangerous in Annex VI of Regulation (EC) No 1272/2008 (CLP). In the Risk assessment report and Risk reduction strategy performed by the Belgian Rapporteur, two main products were analysed during the exposure assessment and throughout the decision making process: the one-component foams and hot melt adhesives, both containing respectively 10% and 2% of MDI. Other products with MDI content below 0.1% did not pose any risk and therefore were excluded by the final consideration on the risk reduction measures under Directive 76/769/EEC. However, polymeric MDI present in mixtures is covered by the restriction when such mixtures contain more than 0.1% of MDI (as defined in the RAR). Therefore, dimers and polymeric forms of MDI are out of the scope of the current restriction except if they are part of mixtures containing more than 0.1% of MDI.

Entry 58 of Annex XVII to REACH - Ammonium Nitrate

Does the derogation to the prohibition of supply of mixtures containing more than 16% of ammonium nitrate in paragraph 2(a) of Entry 58 of Annex XVII cover only downstream users and distributors who have a licence under Council Directive 93/15/EEC on civil explosives (OJ L 010, 16.01.1993 p.19) or whether it covers all downstream users and distributors?

In entry 58, the terms "including natural or legal persons licensed or authorised in accordance with Council Directive 93/15/EEC" should be read as an example of operators that benefit from the exemption. Therefore the derogation in paragraph 2(a) covers all downstream users and distributors as defined in Article 3(13) and 3(14) of REACH. As a consequence, mixtures containing more than 16% of nitrogen in relation to ammonium nitrate may be placed on the market after 27 June 2010 for supply to downstream users and distributors as defined in REACH. As consumers are not downstream users nor distributors, mixtures containing more than 16% of nitrogen in relation to ammonium nitrate may not be placed on the market for supply to consumers.

Can the downstream users acquire ammonium nitrate in order to